Clinical trial NCT03901339
Conditions: Metastatic Breast Cancer
Sponsor: Gilead Sciences
Start date: 2019-05-08; Completion date: 2023-10-20
Enrollment: 543 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

Detailed description:

Arms: arm 1: Participants will receive sacituzumab govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 of a 21-day cycle. arm 2: Participants will receive TPC determined prior to randomization from one of the following single-agent treatment:

Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic)

* Eribulin: 1.4 mg/m\^2 for North American sites, 1.23 mg/m\^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle
* Capecitabine: 1000-1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle
* Gemcitabine: 800-1200 mg/m\^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution
* Vinorelbine: 25 mg/m\^2 via IV on Day 1 weekly cycle per institution
Interventions: intervention 1: Sacituzumab Govitecan-hziy intervention 2: Eribulin intervention 3: Capecitabine intervention 4: Gemcitabine intervention 5: Vinorelbine
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously per NCCN guidelines intervention 3: Administered orally per NCCN guidelines intervention 4: Administered intravenously per NCCN guidelines intervention 5: Administered intravenously per NCCN guidelines

Protocol documents:
Prot_000.pdf: 
Study Title:
Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus 
Treatment of Physician's Choice (TPC) in subjects with Hormonal 
Receptor-Positive (HR+) Human Epidermal Growth Factor 
Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who 
have failed at least two prior chemotherapy regimens
Sponsor:
Gilead Sciences, Inc. (Immunomedics, Inc. is now part of the 
Gilead group of companies)
333 Lakeside Drive
Foster City, CA 94404
USA
IND Number:
122694
EudraCT Number:
2018-004201-33
ClinicalTrials.gov 
Identifier:
NCT03901339
Indication:
Metastatic Breast Cancer
Protocol ID:
IMMU-132-09
Contact Information:
The medical monitor name and contact information will be 
provided on the Key Study Team Contact List.
Protocol 
Version/Date:
Original:
21-Dec-2018
Amendment 01: 03-Jul-2019 (France specific)
Amendment 02: 10-Jul-2019 (Germany specific)
Amendment 03: 04-Feb-2020 (Global) Never Implemented
Amendment 04: 13-Mar-2020 (Global)
Amendment 05: 08-Oct-2020 (Global)
Amendment 06: 27-Jan-2021 (Global)
Amendment 07: 23-Aug-2021 (Global)
This study will be conducted under United States Food and Drug Administration investigational 
new drug application regulations (21 Code of Federal Regulations Part 312); however, sites 
located in the European Economic Area, the United Kingdom, and Switzerland are not included 
under the investigational new drug application and are considered noninvestigational new drug 
application sites.
GILEAi:> 


CONFIDENTIALITY STATEMENT
The information contained in this document, particularly unpublished data, is the property or 
under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable 
institutional review board or independent ethics committee. The information is only to be used 
by you in connection with authorized clinical studies of the investigational drug described in 
the protocol. You will not disclose any of the information to others without written 
authorization from Gilead Sciences, Inc., except to the extent necessary to obtain informed 
consent from those persons to whom the drug may be administered.


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1.
PROTOCOL SYNOPSIS
Name of Sponsor/Company:
Gilead Sciences, Inc. (Immunomedics, Inc. is now part of the Gilead group of companies)
Name of Investigational Product:
Sacituzumab govitecan is an antibody-drug conjugate composed of the humanized monoclonal 
antibody, hRS7 immunoglobulin G (IgG)1κ, which binds to trophoblastic cell-surface 
antigen-2 (Trop-2); the camptothecin-derived agent, SN-38, a topoisomerase I inhibitor; and 
CL2A, a linker, which couples SN-38 to hRS7 IgG1κ.
Title of Study:
Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's 
Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth 
Factor Receptor 2 (HER2-) Negative Metastatic Breast Cancer (MBC) who have failed at least 
two prior chemotherapy regimens 
Study Center(s):
Approximately 125 centers worldwide
Study Duration:
Enrollment is expected to be completed in approximately 24 months and the overall duration 
of the study is expected to be 52 months.
Objectives:
Primary Objective:

To assess and compare efficacy of sacituzumab govitecan to TPC as measured by 
progression-free survival (PFS) as determined by blinded independent central review 
(BICR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in 
subjects with HR+/HER2- MBC who have progressed after cyclin-dependent kinase 
(CDK) 4/6 inhibitor, endocrine therapy, taxane, and after at least 2, but no more than 4 
prior chemotherapy regimens for metastatic disease
Secondary Objectives:

To assess and compare sacituzumab govitecan to TPC in overall survival (OS) in subjects 
with HR+/HER2- MBC who have progressed after CDK 4/6 inhibitor, endocrine therapy, 
taxane and at least 2, but no more than 4 prior chemotherapy treatment regimens for 
metastatic disease


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• 
To assess and compare objective (overall) response rate (ORR), duration ofresponse 
(DOR) and clinical benefit rate (CBR; complete response (CR)+paiiial response 
(PR)+stable disease (SD) with a duration of~ 6 months) between ti·eatment aim s as 
detennined by local investigator review (LIR) and BICR using RECIST 1.1 
• 
To assess and compare the impact of h'eatment on time to deterioration (TTD) of global 
health status/quality of life (QOL), pain, and fatigue domains as measured by European 
Organization for the Reseai·ch and Treatment of Cancer (EORTC) quality of life of cancer 
patients, core questionnaire version 3.0 (QLQ-C30) 
• 
To assess and compare the overall safety and tolerability 
Number of subjects planned: 
Approximately 520 subjects 
Methodology: 
This is an open-label, randomized, multicenter, international Phase 3 study to compare the 
efficacy and safety of sacituzumab govitecan versus TPC in subjects with metastatic or 
locally-recunent inoperable HR+/HER2- MBC who have progressed after a CDK 4/6 
inhibitor, endocrine therapy, a taxane, and at least 2, but no more than 4 prior chemotherapy 
regimens for metastatic disease. Subjects will be randomized in a 1: 1 ratio to either 
sacituzumab govitecan (Investigational Ann A) or TPC (Conti·ol Alm B; i.e., eribulin, 
capecitabine, gemcitabine, or vinorelbine). Randomization will be sh'atified based on prior 
chemotherapy regimens for ti·eatment of metastatic disease (two vs. three/four lines), visceral 
metastasis (YIN), and endocrine therapy in the metastatic setting for at least 6 months (YIN). 
The study will be conducted in two phases, a Pre-randomization Phase and a Randomization 
Phase: 
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
The Pre-randomization Phase will last no longer than 28 days and consists of the following 
two periods:
A Screening Period to establish study eligibility
A Baseline Period to confirm eligibility and establish disease characteristics prior to 
randomization and treatment

The Randomization Phase will begin at the time of randomization of the first subject and 
will end on the data cut-off date for the final analysis of OS; the Randomization Phase 
consists of the following two periods:
A Treatment Period which begins at the time of randomization and ends with the 
completion of the End-of-Treatment (EOT) visit, which will occur at least 30 days after 
the final dose of study treatment
A Follow-up Period which begins the day after the EOT visit and continues as long as 
the subject is alive or until the data cut-off date of the final analysis of OS, unless the 
subject withdraws consent from the study or the Sponsor terminates the study
An independent Data Safety Monitoring Committee (DSMC) will be convened at regular 
intervals to assess the progress of this study and review safety.
Diagnosis and Criteria for Inclusion:
Inclusion Criteria
Subjects must meet all the following inclusion criteria:
1) Female or male subjects, adult or aged ≥ 18 years at the time of signing the informed 
consent form
2) Documented evidence of HR+/HER2- MBC confirmed by a local laboratory with the most 
recently available or newly obtained tumor biopsy (preferably within the last 12 months) 
from a locally recurrent or metastatic site(s) and defined per American Society of Clinical 
Oncologists/College of American Pathologists criteria as:
HR+ (a tumor is considered HR+ if at least 1% of the cells examined have estrogen 
and/or progesterone receptors)
HER2- defined as immunohistochemistry ≤ 2+ or fluorescence in situ hybridization 
negative
3) Availability of archival tumor tissue in a formalin fixed, paraffin embedded (FFPE) block 
(preferably within 12 months prior to consent) or newly acquired biopsy (FFPE block) 
from a metastatic site. Note: Bone biopsies are not allowed


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4) Refractory to or relapsed after at least 2, but no more than 4 prior systemic chemotherapy 
regimens for metastatic disease. Adjuvant or neoadjuvant therapy for early stage disease 
will qualify as one of the required prior chemotherapy regimens if the development of 
unresectable, locally advanced, or metastatic disease occurred within a 12-month period of 
time of the therapy. Note: Treatments for bone metastases (e.g., bisphosphonates, 
denosumab, etc.) and hormonal therapy are not considered as prior systemic chemotherapy 
treatments for advanced disease.
5) Should have been previously treated with:
At least 1 taxane in any setting
At least 1 prior anticancer hormonal treatment in any setting
At least 1 CDK 4/6 inhibitor in any setting
6) Eligible for one of the chemotherapy options listed in the TPC arm
7) Documented disease progression after the most recent therapy by computed tomography 
(CT)/magnetic resonance imaging (MRI)
8) At least 1 measurable target lesion according to RECIST 1.1 (bony disease only is not 
allowed) that meets all of the following criteria:
Lymph node lesion that measures at least ≥ 1.5 cm in the short axis
Non-nodal lesion that measures ≥ 1.0 cm in the longest diameter in the plane of 
measurement
The lesion is suitable for repeat measurement using CT/MRI. Historical CT/MRI scans 
performed within 28 days of C1D1 may be used as screening scans to demonstrate 
eligibility as long as they meet minimum standards as separately defined by the central 
imaging vendor.
Lesions that have had external beam radiotherapy or locoregional therapy must show 
radiographic evidence of disease progression based on RECIST 1.1 to be deemed a 
target lesion.
Brain CT/MRI must be conducted for subjects with a history of brain metastasis. The 
subject must have had stable* brain metastasis for at least 4 weeks. Target lesions 
cannot be from brain.
* Stable brain metastasis is defined as the following:
■
Prior local treatment by radiation, surgery, or stereotactic surgery
■
Imaging – stable or decreasing size after such local treatment
■
Clinically stable signs and symptoms for at least 4 weeks
■
≥ 2 weeks from discontinuation of antiseizure medication
■
Low and stable doses of corticosteroids ≤ 20 mg prednisone or equivalent daily are 
permitted


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9) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
10) Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to the 
Cockcroft and Gault formula
11) Adequate bone marrow function, defined as:
Absolute neutrophil count (ANC) ≥ 1,500 per mm3
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000 per mm3
Note: Blood transfusion or growth factor support is not allowed within 14 days prior to 
screening labs.
12) Adequate liver function, defined as:
Total bilirubin ≤ 1.5× institutional upper limit of normal (IULN) or ≤ 3 IULN for 
patients with documented Gilbert’s syndrome
Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5× IULN 
(in the case of liver metastases ≤ 5× IULN), and serum albumin ≥ 3 g/dL
Alkaline phosphatase (ALP) ≤ 5.0× IULN unless there are bone metastases, in which 
case liver-specific ALP must be separated from the total and used to assess liver 
function instead of total ALP
13) Resolution of all systemic anticancer therapy-related or radiation-related toxicities to 
Grade 1 severity or lower, except for neuropathy (≤Grade 2) and alopecia. Subjects with 
Grade 2 neuropathy are eligible, but should not receive vinorelbine as TPC.
14) Females must not be lactating or pregnant at Baseline (as documented by a negative beta 
human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG] test with 
a minimum sensitivity of 25 IU/L or equivalent units of β-hCG [or hCG]). All females will 
be considered to be of childbearing potential unless they are postmenopausal 
(amenorrhoeic for at least 12 consecutive months, in the appropriate age group, and 
without other known or suspected cause) or have been sterilized surgically (i.e., bilateral 
tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 
1 month before dosing).
15) Females of childbearing potential must not have had unprotected sexual intercourse within 
30 days before study entry and must agree to use a highly effective method of 
contraception (total abstinence [if it is her preferred and usual lifestyle], a contraceptive 
implant, an oral contraceptive, or have a vasectomized partner with confirmed 
azoospermia) throughout the entire study period and for 6 months after study drug 
discontinuation. For sites outside of the European Union (EU), it is permissible that if a 
highly effective method of contraception is not appropriate or acceptable to the subject, 
then the subject must agree to use a medically acceptable method of contraception, i.e., 
double barrier methods of contraception such as condom plus diaphragm or cervical/vault 
cap with spermicide. If currently abstinent, the subject must agree to use a highly effective 
method as described above if she becomes sexually active during the study period or for 


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6 months after study drug discontinuation. Females who are using hormonal contraceptives 
must have been on a stable dose of the same hormonal contraceptive product for at least 
28 days before dosing and must continue to use the same contraceptive during the study 
and for 6 months after study drug discontinuation.
16) Male subjects who are partners of women of childbearing potential must use a condom and 
spermicide and their female partners, if of childbearing potential, must use a highly 
effective method of contraception (see methods described above in Inclusion Criterion 15) 
beginning at least 1 menstrual cycle prior to starting study drug, throughout the entire 
study period, and for 3 months after the last dose of study drug, unless the male subjects 
are totally sexually abstinent or have undergone a successful vasectomy with confirmed 
azoospermia or unless the female partners have been sterilized surgically or are otherwise 
proven sterile.
17) Must be willing and able to comply with all aspects of the protocol
18) Must voluntarily agree to provide written informed consent
19) Could have received an unlimited number of prior endocrine, biological, or targeted 
therapies in the absence of co-administered chemotherapy; all of these therapies must have 
been completed 14 days prior to randomization, except biological therapy which must have 
been completed 28 days prior to randomization
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from the study:
1) Previous treatment with a topoisomerase 1 inhibitor as a free form or as other formulations
2) Current enrollment in another clinical study or used any investigational device or drug 
either within 5 half-lives or 28 days prior to randomization, whichever is longer
3) Treatment with chemotherapy, radiation, or small molecule targeted therapy within 
2 weeks and biological therapy within 4 weeks prior to the first dose of study treatment
4) Existing anticancer treatment-related adverse events (AEs) of Grade ≥ 2 (except for 
alopecia and Grade 2 neuropathy) according to National Cancer Institute (NCI)-CTCAE 
v5.0
5) Any other malignancy that required treatment or has shown evidence of recurrence (except 
for non-melanoma skin cancer or histologically-confirmed complete excision of carcinoma 
in situ) during the 5 years prior to enrollment in this study
6) History of significant cardiovascular disease, defined as:
Congestive heart failure greater than New York Heart Association (NYHA) Class II 
according to the NYHA Functional Classification
Unstable angina or myocardial infarction within 6 months before enrollment
Serious cardiac arrhythmia


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7) Clinically-significant electrocardiogram (ECG) abnonnality, including any of the 
following: 
-
Marked Baseline prolonged QT/QTc interval (i.e., a repeated demonstrntion of a QTc 
interval > 500 ms) demonstrated on ECG at Screening. 
QTcp = QT 
QTcF is calculated by Fridericia's fonnula 
-
Histo1y ofrisk factors for torsade de pointes (e.g., heaii failure, hypokaleinia, fainily 
histo1y of long QT Syndrome) 
8) Has known active central nervous system metastases and/or carcinomatous meningitis. 
Subjects may paiiicipate provided they have stable brain metastasis. All subjects with 
cai·cinomatous meningitis ai·e excluded regai·dless of clinical stability. Stable brain 
metastasis is defined in inclusion criterion 8 
9) Active hepatitis B vims (positive hepatitis B surface antigen) or active hepatitis C vims 
(measurable viral ribonucleic acid (RNA) load with polymerase chain reaction) infection 
10) Scheduled surge1y during the study, other than minor surge1y which would not delay study 
treatment 
11) Has an active serious infection requiring antibiotics 
12) Has active chronic inflammato1y bowel disease (ulcerative colitis, Crohn's disease) and 
subjects with a histo1y of bowel obstmction 
13) Have received a live vaccine within 30 days of randornization 
14) Known hypersensitivity or intolerance to any of the study mu gs or any of the excipients 
15) Any medical or other condition which, in the opinion of the Investigator, causes the subject 
to be medically unfit to receive sacituzumab govitecan or unsuitable for any other reason 
16) Is receiving any medication prohibited in combination with the study treatment(s) as 
described in the respective product labels, unless medication was stopped within 7 days 
prior to randomization 
17) Locally-advanced MBC (stage Ille) in subjects who are candidates for curative intent 
therapy at the time of study enrollment. 
18) If required per local guidelines, any subject with a blood uracil level~ 150 ng/mL is 
excluded from receiving capecitabine as TPC (Note: blood uracil level will be assessed at 
Screening for all subjects eligible to be randomized to capecitabine as TPC) 
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Investigational Product, Dosage and Mode of Administration:
Sacituzumab govitecan 10 mg/kg administered as an intravenous (IV) infusion on Days 1 and 
8 of repeating 21-day cycles. Protocol-defined dose reductions will be permitted. Subjects in 
this group will receive premedications (i.e., antipyretics, H1 blockers, and H2 blockers) for 
prevention of infusion reactions and a 2- or 3-drug combination regimen for prevention and 
treatment of chemotherapy-induced nausea, vomiting, and diarrhea.
Reference Therapy, Dosage and Mode of Administration:
TPC with one of the following:

Eribulin - (1.4 mg/m2 for North American sites, 1.23 mg/m2 for EU sites or per institution) 
is to be administered IV on Days 1 and 8 of a 21-day cycle

Capecitabine - (1000-1250 mg/m2) is to be administered PO twice daily for 2 weeks 
followed by a 1-week rest period given as a 21-day cycle

Gemcitabine - (800-1200 mg/m2) administered IV on Days 1, 8, and 15 of each 28-day 
cycle or per institution

Vinorelbine (25 mg/m2 IV on Day 1 weekly cycle per institution) (Note: subjects with 
grade 2 neuropathy are eligible, but should not receive vinorelbine as TPC)
The use of premedications (i.e., antipyretics, H1 blockers, and H2 blockers) for prevention of 
infusion reactions and medications for prevention and treatment of chemotherapy-induced 
nausea, vomiting, and diarrhea for subjects in this group is based on the Investigator’s 
discretion.
Duration of Treatment:
Subjects will continue to receive study treatment until RECIST 1.1 defined progressive disease 
(PD) by LIR, development of unacceptable toxicity, subject request, withdrawal of consent, 
Investigator decision, pregnancy, or study termination by the Sponsor, or another treatment 
discontinuation criteria is met (see Section 5.4 Criteria for Removal from Study Treatment) 
Criteria for Evaluation:
Efficacy:
Efficacy analyses will be performed using tumor assessments by LIR and BICR using 
RECIST 1.1.
Primary Efficacy End Point:

PFS as determined by BICR using RECIST 1.1
Secondary Efficacy End Points:

OS 

ORR as determined by BICR using RECIST 1.1


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
TTD in the global health status/QOL, pain and fatigue domains of EORTC QLQ-C30 

DOR as determined by LIR and BICR using RECIST 1.1

CBR as determined by LIR and BICR using RECIST 1.1
Safety:
Safety and tolerability will be assessed based on the incidence of adverse events (AEs) and 
serious AEs (SAEs), review of clinical laboratory data (i.e., hematology, chemistry, and 
urinalysis), ECG monitoring, ECOG performance status, vital signs (i.e., heart rate, systolic 
and diastolic blood pressure, respiratory rate, and body temperature), and ADA.
Statistical Methods:
Sample Size Assumptions:
The sample size is estimated based on the primary end point of PFS, but also taking into 
consideration OS as the main secondary end point. An overall sample size of approximately 
520 subjects were randomized in a 1:1 ratio to either sacituzumab govitecan or TPC.
For PFS, assuming a hazard ratio of 0.70 (medians of 5.3 months for sacituzumab govitecan 
and 3.7 months for TPC), a total of 350 PFS events will be used to detect a statistically 
significant difference at a 2-sided alpha of 0.05 with 92% power. With an estimated average 
accrual rate of 22 subjects per month, a total of 520 subjects will provide 350 PFS events 
approximately 27 months after the first subject is randomized, after accounting for events 
being censored because of subjects missing tumor assessments or starting subsequent 
anti-cancer therapies (see primary end point PFS definition in Section 9.5.1). The recruitment 
rate is assumed to be non-uniform so that half of the subjects are recruited 55% of the way 
through the recruitment period of approximately 24 months reflecting the change in sample 
size and actual recruitment rate that was affected by the global coronavirus disease 2019 
(COVID-19) pandemic.
At PFS final analysis, OS will be summarized descriptively only. To be conservative, the 
nominal 2-sided alpha of 0.00001 will be spent even without formal hypothesis testing. For 
OS, assuming a hazard ratio of 0.73 (medians of 16.5 months in Arm A and 12 months in Arm 
B), a total of 438 OS events are needed to detect a statistically significant difference with 
86.7% power at a 2-sided alpha of 0.04999 based on a recruitment period of approximately 
24 months and 52 months of survival follow-up from the first subject randomized.
The Sponsor will closely monitor the number of subjects randomized and discontinued, 
including subjects who refuse study treatment assigned. As the primary analysis is triggered by 
a targeted number of PFS events, subjects who prematurely discontinue from the study or 
whose events are censored do not count toward the targeted number. To compensate for such 
cases, an additional number of subjects is necessary to be enrolled to ensure the targeted 
number of events is reached within a reasonable timeframe. If required, the additional number 
of subjects will be determined by the Sponsor on the basis of the number and pattern of 
accumulated and censored events at the appropriate times as the study progresses.


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Multiplicity Adjustment:
The overall type I error rate for this study is strictly controlled at a 2-sided alpha of 0.05. The 
primary end point analysis of PFS assessed by BICR will serve as the gatekeeper for the 
secondary end point analyses and be tested at the 2-sided alpha of 0.05. At PFS final analysis, 
OS will be summarized descriptively only. To be conservative, the nominal 2-sided alpha of 
0.00001 will be spent even without formal hypothesis testing. If the primary PFS analysis is 
positive, analysis of the main secondary end point of OS will be formally tested sequentially at 
the 2-sided alpha of 0.04999, ORR (assessed by BICR) and analysis for QOL will be formally 
tested sequentially at the 2-sided alpha of 0.05 respectively when the above hypotheses in the 
hierarchy are also statistically significant. For analysis of QOL, TTD of global health 
status/QOL, pain, and fatigue domains as measured by EORTC QLQ-C30 will be tested.
Analysis Populations:
The following populations will be defined and used for analysis:

Screened Set is the group of all subjects who have signed an informed consent and 
participated in screening procedures at the investigative site to assess eligibility. This 
analysis population is used for selected tables and listings pertaining to subjects’ 
disposition and eligibility criteria.

Full Analysis Set (Intent-to-Treat Analysis [ITT] Population) is the group of all 
randomized subjects. This is the primary analysis population for all efficacy analyses 
which will be based on the ITT principle, with subjects analyzed according to the 
randomized treatment assignment.

Safety Analysis Set is the group of subjects who received at least 1 dose of study drug. 
This is the analysis population for all safety analyses which will be based on the actual 
treatment received.

HRQoL-Evaluable Set is the all ITT population who had an evaluable assessment of the 
HRQoL at baseline and at least one evaluable assessment at post-baseline visits. An 
evaluable assessment at a given visit will be defined as at least one of the 15 
domains/scales were non-missing at that scheduled assessment visit.

PK Set is defined as Safety population subjects who have completed at least one cycle of 
sacituzumab govitecan treatment and have at least one non-missing PK concentration of 
total SN-38, free SN-38, total antibody (hRS7 IgG) and/or SN-38G
Primary End Point (Primary Analysis)
PFS will be described using Kaplan-Meier (K-M) estimates. The primary analysis of PFS for 
the comparison between treatment arms will be performed using a stratified log rank test with 
the stratification factors used in the randomization. Median PFS and its 95% CI as determined 
by the Brookmeyer and Crowley method with log-log transformation will be presented and the 
K-M estimates of PFS will be plotted over time. Hazard ratio of PFS and its 95% CI will be 
estimated using Cox proportional-hazards model stratified by the same stratification factors 
used in the randomization.


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Secondary End Points (Secondary Analyses)
OS will be described using K-M estimates. The primary analysis of OS for comparison 
between treatment arms will be performed using a stratified log rank test with the same 
stratification factors used in the randomization. Median OS and the associated 95% CI as 
determined by the Brookmeyer and Crowley method with log-log transformation will be 
presented. Hazard ratio and the associated 95% CI will be estimated using a Cox 
proportional-hazards model stratified by the same stratification factors used in the 
randomization.
ORR will be analyzed and compared between the treatment arms using the Cochran Mantel 
Haenszel (CMH) test stratified by the stratification factors used in the randomization. The 2- 
sided 95% CIs will be calculated using the Clopper-Pearson exact method.
CBR will be calculated with exact 95% CIs using the method of Clopper and Pearson. CBR 
will be compared between treatment arms using a CMH test stratified by the stratification 
factors used in the randomization. The differences and odds ratios of these rates between 
treatment arms and 95% CIs will be calculated respectively.
The K-M estimates of median DOR and its 95% CI will be calculated for responders (CR or 
PR) in each treatment arm.
Time to deterioration of global health status/QOL, pain, and fatigue domains as measured by 
EORTC QLQ-C30 will be analyzed similarly as the primary analysis of PFS.
Safety Analyses
Safety analyses will be performed using the Safety Analysis Set and will be summarized using 
descriptive statistics. Categorical variables will be summarized by number and percentage. 
Continuous variables will be summarized using number of subjects, mean, standard deviation, 
median, upper and lower quartiles, and range (minimum and maximum).
This study will be conducted in accordance with the guidelines of Good Clinical Practice, 
including archiving of essential documents.


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TABLE OF CONTENTS
1.
PROTOCOL SYNOPSIS.......................................................................................................................................3
TABLE OF CONTENTS..............................................................................................................................................14
LIST OF APPENDICES...............................................................................................................................................16
LIST OF IN-TEXT TABLES .......................................................................................................................................16
LIST OF IN-TEXT FIGURES......................................................................................................................................17
LIST OF ABBREVIATIONS.......................................................................................................................................18
2.
INTRODUCTION................................................................................................................................................21
2.1.
Metastatic Breast Cancer.........................................................................................................................21
2.2.
Sacituzumab Govitecan...........................................................................................................................22
2.3.
Summary of Nonclinical Findings...........................................................................................................23
2.3.1.
Pharmacology Studies ...........................................................................................................23
2.3.2.
Pharmacokinetics...................................................................................................................23
2.3.3.
Toxicology.............................................................................................................................23
2.4.
Summary of Clinical Studies...................................................................................................................24
2.4.1.
Pharmacokinetics...................................................................................................................25
2.4.2.
Immunogenicity.....................................................................................................................26
2.4.3.
Efficacy in Metastatic Breast Cancer ....................................................................................26
2.4.4.
Safety Data ............................................................................................................................30
2.5.
Rationale for the Study............................................................................................................................31
2.6.
Rationale for Dose Regimen ...................................................................................................................31
2.7.
Risk/Benefit Assessment for the Study ...................................................................................................31
2.8.
Compliance..............................................................................................................................................31
3.
STUDY OBJECTIVES ........................................................................................................................................32
3.1.
Primary Objective....................................................................................................................................32
3.2.
Secondary Objectives ..............................................................................................................................32
4.
INVESTIGATIONAL PLAN ..............................................................................................................................34
4.1.
Overall Study Design ..............................................................................................................................34
4.2.
Data Safety Monitoring Committee ........................................................................................................34
4.3.
End Points................................................................................................................................................35
4.3.1.
Efficacy..................................................................................................................................35
4.3.2.
Safety.....................................................................................................................................35
4.4.
Duration of Study ....................................................................................................................................35
5.
SUBJECT POPULATION...................................................................................................................................36
5.1.
Inclusion Criteria.....................................................................................................................................36
5.2.
Exclusion Criteria....................................................................................................................................39
5.3.
Number of Subjects and Treatment Assignment.....................................................................................40
5.4.
Criteria for Removal from Study Treatment ...........................................................................................41
6.
TREATMENT OF SUBJECTS............................................................................................................................42
6.1.
Investigational Product, Dosage, and Mode of Administration ..............................................................42
6.1.1.
Description ............................................................................................................................42
6.1.2.
Packaging and Labeling ........................................................................................................42
6.1.3.
Storage...................................................................................................................................42
6.1.4.
Preparation.............................................................................................................................42
CCI


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6.1.5.
Premedications ......................................................................................................................42
6.1.6.
Administration.......................................................................................................................43
6.1.7.
Management of Sacituzumab Govitecan Toxicity ................................................................43
6.1.8.
Drug Interactions...................................................................................................................47
6.1.9.
Drug Accountability and Destruction....................................................................................48
6.2.
Treatment of Physician’s Choice.............................................................................................................48
6.3.
Concomitant Medications and Procedures ..............................................................................................49
6.3.1.
Prohibited Concomitant Medications and Procedures ..........................................................49
6.3.2.
Permitted Concomitant Medications and Procedures............................................................50
6.3.3.
QT-Prolonging Drugs............................................................................................................50
7.
STUDY PROCEDURES......................................................................................................................................51
7.1.
Informed Consent ....................................................................................................................................51
7.2.
Subject Registration.................................................................................................................................51
7.3.
Demographics, Medical History, Prior and Concomitant Medications ..................................................51
7.4.
Tumor Assessments.................................................................................................................................52
7.4.1.
Screening ...............................................................................................................................52
7.4.2.
CT or MRI Tumor Assessments............................................................................................53
7.5.
Quality of Life .........................................................................................................................................53
7.6.
Assessment of Safety...............................................................................................................................54
7.6.1.
Physical Examinations...........................................................................................................54
7.6.2.
Vital Signs .............................................................................................................................54
7.6.3.
ECGs......................................................................................................................................54
7.6.4.
Laboratory Assessments........................................................................................................55
7.6.5.
ECOG Performance Status....................................................................................................55
7.6.6.
Adverse Events and Serious Adverse Events Reporting.......................................................55
7.7.
Immunogenicity.......................................................................................................................................63
7.8.
Pharmacokinetic Evaluations ..................................................................................................................63
7.9.
UGT1A1 Genotype .................................................................................................................................63
7.10.
Blood Biomarker Evaluations .................................................................................................................63
8.
SCHEDULE AND SEQUENCE OF PROCEDURES ........................................................................................65
8.1.
Pre-Randomization Phase........................................................................................................................65
8.2.
Randomization Phase ..............................................................................................................................65
8.2.1.
Treatment Period ...................................................................................................................65
8.2.2.
Follow-up Period...................................................................................................................66
8.3.
End of Study............................................................................................................................................66
9.
STATISTICAL CONSIDERATIONS.................................................................................................................67
9.1.
Determination of Sample Size.................................................................................................................67
9.2.
Interim Analysis ......................................................................................................................................67
9.3.
Multiplicity..............................................................................................................................................68
9.4.
Analysis Sets ...........................................................................................................................................69
9.5.
Efficacy Analyses....................................................................................................................................70
9.5.1.
Primary Efficacy Analyses....................................................................................................70
9.5.2.
Secondary Efficacy Analyses................................................................................................71
9.5.3.
Sensitivity Analyses ..............................................................................................................73
9.5.4.
Subgroup Analyses................................................................................................................73
9.6.
Safety Analyses .......................................................................................................................................75
10.
TREATMENT COMPLIANCE...........................................................................................................................76
11.
QUALITY CONTROL AND QUALITY ASSURANCE ...................................................................................77
CCI-


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12.
DATA HANDLING AND RECORD KEEPING................................................................................................78
12.1.
Electronic Case Report Forms.................................................................................................................78
12.2.
Record Retention.....................................................................................................................................78
12.3.
Good Clinical Practice.............................................................................................................................78
12.4.
Ethical Considerations.............................................................................................................................79
12.5.
Subject Information and Consent ............................................................................................................79
12.6.
Protocol Compliance ...............................................................................................................................80
12.7.
Site Monitoring and On-Site Audits........................................................................................................80
12.8.
Subject Data Protection ...........................................................................................................................81
12.9.
Financial Disclosure ................................................................................................................................81
12.10. Sponsor Discontinuation Criteria ............................................................................................................82
13.
DISSEMINATION AND PUBLICATION OF RESULTS.................................................................................83
14.
REFERENCES.....................................................................................................................................................84
15.
APPENDICES......................................................................................................................................................87
LIST OF APPENDICES
Appendix 1.
Signature Page .........................................................................................................................88
Appendix 2.
ECOG Performance Status Evaluation....................................................................................89
Appendix 3.
Procedure for Collection, Storage, and Shipment of Blood and Tissue Samples....................90
Appendix 4.
Schedule of Procedures/Assessments......................................................................................91
Appendix 5.
Quality of Life Questionnaires ................................................................................................96
Appendix 6.
RECIST 1.1 ...........................................................................................................................104
Appendix 7.
Child-Pugh Score in Subjects with Hepatic Impairment.......................................................107
Appendix 8.
Medications Affecting QT Interval .......................................................................................108
Appendix 9.
UGT1A1 Inducers and Inhibitors..........................................................................................110
Appendix 10.
Pandemic Risk Assessment and Mitigation Plan ..................................................................111
LIST OF IN-TEXT TABLES
Table 1.
Low Response Rates and Progression-Free Survival to Chemotherapy in 
Pre-Treated Metastatic Breast Cancer .....................................................................................22
Table 2.
Summary of Mean (± Standard Deviation) Sacituzumab Govitecan and Free SN-38 ............25
Table 3.
Demographics and Subject Characteristics of HR+/HER2- MBC Subjects from 
IMMU-132-01 Basket Study...................................................................................................27
Table 4.
Overall Response Assessment Analyses in Various Subject Subsets .....................................28
Table 5.
Recommended Dose Reduction Schedule for Sacituzumab Govitecan ..................................45
Table 6.
Laboratory Assessments..........................................................................................................55
Table 7.
Grading for Adverse Events Not Listed in NCI-CTCAE........................................................60
Table 8.
Classification for Study Drug Action Taken with Regard to an Adverse Event.....................62
Table 9.
Classifications for Outcome of an Adverse Event...................................................................62


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LIST OF IN-TEXT FIGURES
Figure 1.
Waterfall Graph of Subjects with at Least 1 Computerized Tomography Assessment 
of Response to Sacituzumab Govitecan (N=54)......................................................................28
Figure 2.
Response Onset and Durability of Response (N=17)..............................................................29
Figure 3.
Progression-free Survival for 54 HR+/HER2-Negative Metastatic Breast Cancer 
Subjects: Administered Sacituzumab Govitecan (ITT Population).........................................29
Figure 4.
Hierarchical Testing Procedures..............................................................................................69


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LIST OF ABBREVIATIONS
ADA
ADC
AE
ALP
ALT
ANC
ASCO
AST
AUC
AUC0-168
BICR
β-HCG
BUN
CAP
CBC
CBR
CDK
CFR
CI
Cl
Cmax
CMH
COVID-19
CR
CT
ctDNA
CTCAE
DOR
DSMC
EBRT
ECG
ECOG
eCRF
EORTC
EOT
ER
EU
EuroQOL
FDA
FFPE
GCP
hCG
HER2-
HIPAA
antidrug antibodies
antibody drug conjugate
adverse event
alkaline phosphatase
alanine aminotransferase
absolute neutrophil count
American Society of Clinical Oncology
aspartate aminotransferase
area under the curve
area under plasma concentration curve through 168 hours
blinded independent central review
beta human chorionic gonadotropin
blood urea nitrogen
College of American Pathologists
complete blood count
clinical benefit rate
cyclin-dependent kinase
Code of Federal Regulation
confidence interval
clearance
maximum concentration
Cochran Mantel Haenszel
coronavirus disease 2019
complete response
computed tomography
circulating tumor DNA
Common Terminology Criteria for Adverse Events
duration of response
Data Safety Monitoring Committee
external beam radiotherapy
Electrocardiogram
Eastern Cooperative Oncology Group
electronic case report form
European Organization for Treatment of Cancer
End-of-Treatment
estrogen receptor
European Union
European Quality of Life
Food and Drug Administration
formalin-fixed parafin embedded
Good Clinical Practice
human chorionic gonadotropin
human epidermal growth factor receptor 2 negative
Health Insurance Portability and Accountability Act


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HR
HR+
HRQOL
IB
ICF
ICH
IEC
IgG
IND
IRB
ITT
IULN
IV
IWRS
K-M
LD
LIR
LN
MBC
MRI
MTD
mTOR
NCI
NCI-CTCAE
NCCN
NYHA
OR
ORR
OS
PD
PFS
PK
PO
PR
PRO
PRO-CTCAE™
QLQ-C30
QOL
RECIST 1.1
RNA
SAE
SD
SD
SUSAR
t½
TPC
hormonal receptor
hormonal receptor-positive
Health-Related Quality of Life
Investigator’s Brochure
informed consent form
International Council for Harmonisation
Independent Ethics Committee
immunoglobulin G
Investigational New Drug
Institutional Review Board
Intent-to-Treat
institutional upper limit of normal
intravenous(ly)
Interactive Web-Based Response System
Kaplan-Meier
Longest diameter
local investigator review
lymph node
metastatic breast cancer
Magnetic resonance imaging
maximum tolerated dose
mammalian target of rapamycin
National Cancer Institute
National Cancer Institute Common Terminology Criteria for AEs
National Comprehensive Cancer Network
New York Heart Association
objective response, OR=CR+PR
objective (overall) response rate
overall survival
progressive disease
progression-free survival
pharmacokinetic(s)
orally
partial response
patient-reported outcome(s)
Patient Reported Outcomes version of the CTCAE
EORTC Quality of Life for Cancer Patients core questionnaire version 3.0
quality of life
Response Evaluation Criteria in Solid Tumors version 1.1
ribonucleic acid
serious adverse event
stable disease
standard deviation
suspected unexpected serious adverse reaction
terminal elimination half-life
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TROPiCS
Trop-2
TNBC
TTD
UGT1A1
US
Vz
WBC
Trop-2 Investigation in Cancer with sacituzumab govitecan
Trophoblastic cell-surface antigen 2
Triple-Negative Breast Cancer
time to deterioration
uridine diphosphate-glucuronosyl transferase 1A1
United States
volume of distribution of the terminal elimination phase
white blood cells


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2.
INTRODUCTION
2.1.
Metastatic Breast Cancer
In 2018, an estimate of 266,120 new cases of breast cancer were diagnosed in the United States 
(US) with nearly 90% of these surviving 5 years or longer (SEER.cancer.gov). Approximately 
41,000 breast cancer related deaths are estimated to occur in 2018. The most common breast 
cancer subtype is hormonal receptor positive (HR+) and human epidermal growth factor 
receptor 2 negative (HER2-), representing approximately 70-80% of all new cases {Setiawan 
2009}.
The most common site of metastatic disease is bone, requiring use of bisphosphonates in 
conjunction with these other therapies. Once metastatic, patients become endocrine- and 
chemotherapy-refractory and there are no further treatment options. As per National 
Comprehensive Cancer Network (NCCN) guidelines, after no response to 3 sequential regimens 
including chemotherapy, palliative care is the only remaining option. European Society for 
Medical Oncology guidelines recommend sequential monotherapy. Only 24% of patients with 
metastatic disease survive more than 5 years and the disease often becomes refractory to 
treatment {Harb 2015}. Progression-free survival (PFS) after endocrine therapy in 
postmenopausal women ranges from 4.1-15.0 months (Table 1){Cortes 2015, Jones 1995, 
Kaufman 2015, Perez 2010a, Twelves 2016}.
First-line treatment for metastatic HR+/HER2- breast cancer is usually endocrine therapy 
(typically aromatase inhibitors), cyclin-dependent kinase (CDK) 4/6 inhibitors in combination 
with hormonal therapy, or, for patients with rapidly progressing or extensive visceral metastatic 
disease, chemotherapy. According to NCCN guidelines, preferred chemotherapy regimens 
include single-agent anthracyclines, taxanes, antimetabolites, and microtubule-inhibitors. 
Combination chemotherapy may also be used in some situations, such as high tumor burden, 
rapidly progressive disease (PD), or visceral crisis.
Efficacy in second- and third-line metastatic treatments continue to be significantly lower, with 
PFS ranging from 3-5.3 months, further representing an unmet clinical need (Table 1). Even with 
the recent approvals of CDK inhibitors, including CDK 4/6 inhibitors (palbociclib, ribociclib, 
and abemaciclib), PFS ranged from 9.5 months to 16.4 months in earlier lines of treatment and 
patients still became refractory, therefore requiring cytotoxic therapy {Cristofanilli 2018, 
Hortobagyi 1983, Sledge 2017}.


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Table 1.
Low Response Rates and Progression-Free Survival to Chemotherapy 
in Pre-Treated Metastatic Breast Cancer
Drug
N*
Population
HR+ 
(%)
ORR%
PFS 
months
OS 
months
Source
Ixabepilone
126
Prior A, T and 
Capecitabine
52
18.3
3.1
8.6
{Perez 2010b}
Capecitabine
548
Prior A, T 
≤ 3 prior chemo 
(incl. adjuvant)
47
19.9
4.2
14.5
{Kaufman 2015}
Capecitabine 
HR+ subgroup
219
Idem
100
NA
5.3
16.8
{Twelves 2016}
Eribulin HR+ 
subgroup
198
Idem
100
NA
4.3
18.2
{Twelves 2016}
Eribulin
508
Prior A and T, 
≥ 2 prior chemo
64
13
3.7
13.1
{Cortes 2015}
Vinorelbine
115
Prior A, 
≤ 2 lines
51
13
3**
7.5
{Jones 1995}
Abbreviations: A= Anthracycline; HR+=hormonal receptor-positive; ER=estrogen receptor ORR=objective (overall) response 
rate; OS=overall survival; PFS=progression free survival; T=taxane
* N represents metastatic breast cancer population with includes HER2+ and/or triple negative breast cancer; ORRs are based on 
local review
** Time to treatment failure
2.2.
Sacituzumab Govitecan
Sacituzumab govitecan (IMMU-132) is an antibody-drug conjugate (ADC) composed of hRS7, a 
humanized immunoglobulin G (IgG)1κ monoclonal antibody, SN-38, a camptothecin analog, 
and CL2A, a linker which couples SN-38 to hRS7. Trophoblastic cell-surface antigen-2 (Trop-2) 
is a cell surface antigen overexpressed in many epithelial cancers and has been linked to 
aggressive disease and a poor prognosis. The antibody component binds to Trop-2 such that the 
ADC concentrates on tumor cell surfaces. SN-38 is the active metabolite of irinotecan and a 
topoisomerase I inhibitor that induces single-stranded DNA breaks during replication. If 
unrepaired, these breaks progress to double-stranded DNA breaks and results in cell death. The 
CL2A linker is unique in that it is subject to pH-dependent hydrolysis. Following internalization 
of the ADC-antigen complex, SN-38 is released in the acidic lysosome and kills the target cells. 
In addition, SN-38 can be cleaved from extracellular, surface-bound ADC due to the acidic pH 
of the tumor microenvironment. The released drug diffuses into neighboring cells in an 
antigen-independent manner and this leads to the death of cells in the immediate proximity of 
target-expressing cells. These two mechanisms of action combine to enable sacituzumab 
govitecan to target and kill cancer cells that over-express Trop-2 as well as other cells in the 
tumor with low or no Trop-2 expression.


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2.3.
Summary of Nonclinical Findings
2.3.1.
Pharmacology Studies
Sacituzumab govitecan showed significant cytotoxicity against 6 different epithelial tumor cell 
lines (i.e., PC-3 [prostate], Calu-3, COLO 205, Capan-1, SK-MES-1 and BxPC-3), with median 
inhibitory concentrations ranging from 1.95 nM to 23.14 nM {Cardillo 2011}.
Significant antitumor effects were seen with the hRS7-SN-38 conjugate compared to free SN-38, 
irinotecan, or an irrelevant IgG-SN-38 conjugate in murine xenografts of variety of human 
epithelial cancers {Cardillo 2015, Cardillo 2011, Goldenberg 2015}.
2.3.2.
Pharmacokinetics
In a 3-month repeat-dose study in Cynomolgus monkeys, a dose-proportional increase in 
exposure (i.e., maximum concentration [Cmax] and area under the curve [AUC]) was seen for 
sacituzumab govitecan, total antibody, total SN-38, and free SN-38, with no relevant gender 
differences after the first dose. Serum half-life ranged from 67.3 to 152 hours. On average 
the amount of free SN-38 in circulation was low (<3% free SN-38 compared with total SN-38 
bound to sacituzumab govitecan), confirming that the majority of SN-38 administered as 
sacituzumab govitecan remains bound to ADC in serum and is not circulating as the free 
cytotoxic payload. The inactive metabolite, SN-38G, readily appeared in serum with mean time 
of maximum concentration ranging from 4.0 to 12 hours.
2.3.3.
Toxicology
In acute toxicity studies in Swiss-Webster mice, sacituzumab govitecan at doses of up to 
750 mg/kg/dose (i.e., cumulative doses of up to 1500 mg/kg) caused minimal loss (<10%) in 
body weight. There was no evidence of hematological toxicity and no abnormal histology 
findings. Transient increases in hepatic transaminases were observed that returned to normal by 
the end of the study.
In Cynomolgus monkeys, sacituzumab govitecan 50 mg/kg/dose (human equivalent dose 
= 16 mg/kg/dose) for 4 treatment cycles (Days 1 and 8 of a 21-day cycle) was considered the 
no-observed-adverse-effect level; a 120 mg/kg/dose administered 3 days apart was associated 
with lethality. Target organs in monkeys included the gastrointestinal tract (necrosis, erosions, 
inflammation, fibrosis, hemorrhage, edema), bone marrow (reduced cellularity) with 
concomitant reductions in red blood cells, white blood cells and platelets; female reproductive 
tract; lymphoid organs (lymphoid depletion); kidney (periarteritis); and skin (hair loss, 
pigmentation).
Local tolerance was evaluated in the Good Laboratory Practices-compliant monkey studies. 
Changes were observed at the injection site, including mild to moderate perivascular 
hemorrhage, moderate hemorrhage in the dermis and subcutis, and minimal to mild perivascular 
mixed cell infiltration. These changes were interpreted as related to procedural trauma and not to 
study drug.


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SN-38 was not mutagenic in a bacterial reverse mutation test or clastogenic in an in vitro 
mammalian cell micronucleus test. Carcinogenicity studies and fertility, early embryonic 
development, and pre- and post-natal development studies with sacituzumab govitecan have not 
been conducted. However, SN-38 is a camptothecin and hence is likely to be carcinogenic. 
Furthermore, SN-38 is a known developmental toxigen {CAMPTOSAR 2014}.
2.4.
Summary of Clinical Studies
Three clinical studies with sacituzumab govitecan are ongoing: 1) a Phase 1/2 study, 
IMMU-132-01, in subjects with relapsed/refractory, metastatic epithelial cancers, including 
metastatic breast cancer (MBC); 2) a Phase 2 study, IMMU-132-06, in subjects with metastatic 
urothelial cancer who have failed either a platinum-based regimen or anti-PD1-based 
immunotherapy; and 3) a Phase 3 study IMMU-132-05 (ASCENT) comparing sacituzumab 
govitecan to treatment of physician’s choice (TPC) in subjects with relapsed/refractory 
metastatic triple-negative breast cancer (TNBC). Data from the Phase1/2 study, IMMU-132-01, 
are provided below.
Study IMMU-132-01 is a multicenter study in the US to evaluate the safety, toxicity, and 
pharmacokinetics (PK) of sacituzumab govitecan. Over 500 subjects with relapsed/refractory, 
metastatic epithelial cancers have been enrolled in the study, including 215 heavily-pretreated 
subjects with MBC, 54 of whom are HR+/HER2-. The starting dose for the Phase 1 portion was 
8 mg/kg administered on Days 1 and 8 of a 21-day cycle. After evaluation at this and higher 
doses in a 3+3 Phase 1 dose-finding design, 8 and 10 mg/kg sacituzumab govitecan administered 
on Days 1 and 8 of a 21-day cycle were chosen for further Phase 2 evaluation in patients with the 
following cancers: breast cancer, non-small-cell lung cancer, small-cell lung cancer, colorectal 
cancer, pancreatic cancer, urothelial cancer, endometrial cancer, and esophageal cancer.
Initially in Phase 2, subjects were recruited in a sequential manner to the 8 mg/kg dose and 
subsequently to the 10 mg/kg dose. An interim analysis was performed when 81 and 97 subjects 
with different tumor types had been treated at the two dose levels, respectively. The duration of 
treatment in the 8 and 10 mg/kg groups was similar and no important safety differences between 
the groups were seen. However, the 10 mg/kg dose was associated with a slightly better 
objective (overall) response rate (ORR) and clinical benefit rate (CBR) {Ocean 2017}. Based on 
these data, the Sponsor decided that further subject accrual would proceed at the 10 mg/kg dose 
level.
Additionally, sacituzumab govitecan has demonstrated promising tumor responses in multiple 
patient populations, including patients with advanced, relapsed/refractory MBC HR+/HER2- 
(31% [17/54]; {Bardia 2018}), urothelial carcinoma (30.6% [11/36]; {Tagawa 2017}), non-small 
lung cancer (19% [9/47];{Heist 2017}), small-cell lung cancer (14% [7/50]; {Gray 2017}), and 
others. Summaries of data from these trials are provided in the sacituzumab govitecan 
Investigator’s Brochure (IB). In these studies, sacituzumab govitecan was more tolerable than 
when SN-38 is administered as the parent compound, irinotecan, or with other 
non-tumor-targeting SN-38 products.


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2.4.1.
Pharmacokinetics
The serum PK of sacituzumab govitecan and free SN-38 were evaluated in subjects with 
metastatic TNBC who received 10 mg/kg sacituzumab govitecan in the Phase 1/2 study, 
IMMU-132-01. PK parameters for sacituzumab govitecan and free SN-38 were determined by 
noncompartmental analysis and are presented in Table 2.
Table 2.
Summary of Mean (± Standard Deviation) Sacituzumab Govitecan 
and Free SN-38 
Sacituzumab Govitecan 
Free SN-38
Cmax 
[ng/mL]
AUC0-168
[h ng/mL]
t1/2
[h]
Vz 
[L/kg]
Cl
[L/h/kg]
Cmax 
[ng/mL]
AUC0-168
[h ng/mL]
t1/2
[h]
 
n=43
n=42
n=42
n=42
n=42
n=43
n=37
n=37
Mean
243,000  
5,210,000  
15.6  
0.0450  
0.00202  
127  
3,900  
17.7  
SD
45,600  
1,230,000  
2.90  
0.0114  
0.000477  
59.7  
1,830  
4.74  
AUC0-168=area under plasma concentration curve through 168 hours; Cl= clearance; Cmax=maximum plasma concentration; 
SD=standard deviation; t½=terminal elimination half-life; Vz=volume of distribution of the terminal elimination phase
Distribution
The maximum concentrations of sacituzumab govitecan and SN-38 occurred close to the end of 
infusion. The mean volume of distribution of the terminal elimination phase (Vz) 
for sacituzumab govitecan was 0.0450 L/kg. 
SN-38 is highly protein bound to human plasma proteins (approximately 95%). The plasma 
protein to which SN-38 predominantly binds is albumin. The relative amount of free SN-38 
compared to total SN-38 was small and was less than or equal to 16.9% for all time points, 
averaging below 7.14%.
Elimination
Following administration of 10 mg/kg sacituzumab govitecan, the clearance of 
sacituzumab govitecan was calculated by noncompartmental analysis to be 0.00202 L/h/kg. 
SN-38 appeared to follow metabolite kinetics, with the elimination of SN-38 appearing to be 
limited by its rate of release from sacituzumab govitecan.  
Metabolism
No metabolism studies with sacituzumab govitecan have been conducted. SN-38 is known to 
be metabolized via human uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1).  


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2.4.2.
Immunogenicity
As with all therapeutic proteins, there is potential for an immune response 
to sacituzumab govitecan.  Based on available data for 420 subjects in the Phase 1/2 study, 
IMMU-132-01, the rate of treatment-emergent and persistent antidrug antibodies (ADA) is very 
low and has been limited to 3 subjects (0.7%). An additional 17 subjects (4%) had transient 
ADA. None of the subjects with treatment-emergent, confirmed ADA had infusion-related 
hypersensitivity adverse events (AEs). 
2.4.3.
Efficacy in Metastatic Breast Cancer
Overall, 54 subjects with estrogen HR+/HER2- MBC have been treated with 10 mg/kg 
sacituzumab govitecan in the Phase 1/2 study, IMMU-132-01 {Bardia 2018}. Demographic data 
are summarized in Table 3.
All subjects were treated at a starting dose of 10 mg/kg, with a median of 11 doses (range: 1-74); 
median time on treatment was 4.0 months (0.2 – 26.0 months). Twelve (22%) subjects had a 
dose reduction to 7.5 mg/kg; 9% occurring in the first cycle. Thirty-four subjects are in 
long-term follow-up, with 11 subjects still on treatment; 18 subjects have died; 1 subject is lost 
to follow-up after 5.3 months; and data for 1 subject are currently not available.
ORR based on investigator assessment and Response Evaluation Criteria in Solid Tumors, 
version 1.1 (RECIST 1.1) was 31% (17/54 subjects; 95% confidence interval [CI]: 19.5%, 
45.6%) (Table 4 and Figure 1). All responses were partial responses (PRs); no complete 
responses (CR) were seen. An additional 31% of subjects had stable disease (SD), with 9 of 
17 subjects having SD for ≥ 6 months, for a CBR of 48%. CBR was also 48% in subjects with 
liver involvement. Median duration of response (DOR) is currently 7.4 months (95% CI: 4.4, 
18.3), with a median onset of response of 2.3 months (1.5 to 7.8 months). Fourteen of the 
17 responders were on-study for 6+ months and 7 are still receiving treatment (Figure 2). Of the 
remaining 20 subjects, 14 reported objective progression of disease and 6 discontinued the study 
without a post-treatment tumor assessment. Median PFS was 6.8 months (95% CI: 4.6, 9.3; 
Figure 3).


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Table 3.
Demographics and Subject Characteristics of HR+/HER2- MBC 
Subjects from IMMU-132-01 Basket Study
Demography
N=54
Female/male, n
54/0
Median age, years (range)
54 (33-79)
ECOG performance status, %
0
1
Missing
35
56
9
Median time from metastatic disease to study entry, years (range)
3.50
(0.14-18.11)
≥ 1 prior chemotherapy for metastatic disease
≥ 2 prior chemotherapy regimens for metastatic disease
Median number of metastatic chemotherapy lines (range)
96
76
2 (0-11)
Prior chemotherapy for metastatic disease, %
Taxanes – any setting
Anthracyclines – any setting
Taxane and Anthracyclines – any setting
Metastatic Taxane
Platinum agents
Fluoropyrimidine agents
Eribulin
Hormonal agents for metastatic disease
CDK 4/6 inhibitors, %
mTOR inhibitor, %
93
69
67
57
24
78
33
100
69
54
Number of metastatic sites at study entry, %
1
2
3+
Sites of metastatic disease at study entry, %
Lung/mediastinum
Bone
Chest wall
Brain
Liver
24
38
33
31
100
37
0
81
CDK=cyclin-dependent kinase; ECOG=Eastern Cooperative Oncology Group; HER2-=human epidermal growth factor receptor 
2 negative; HR=hormonal receptor; mTOR=mammalian target of rapamycin


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Table 4.
Overall Response Assessment Analyses in Various Subject Subsets
Subject Subset
ORR, % (n/N)
Overall
31 (17/54)
Age
<65
≥ 65
29 (12/42)
42 (5/12)
Onset of metastatic disease from diagnosis
< 1 year
≥ 1 year
15 (2/3)
37 (15/41)
≥ 2 prior chemos for metastatic disease
< 2 prior chemos for metastatic disease
29 (12/41)
38 (5/13)
Prior CDK 4/6 inhibitors
No prior CDK 4/6 inhibitors
24 (9/37)
47 (8/17)
Visceral involvement at study entry (Liver/Lung)
Yes
No
Liver involvement
(More than 2 Metastates=95%)
27 (13/48)
67 (4/6)
27 (12/44)
CDK=cyclin-dependent kinase; ORR=objective (overall) response rate
Figure 1.
Waterfall Graph of Subjects with at Least 1 Computerized 
Tomography Assessment of Response to Sacituzumab Govitecan 
(N=54)
.20 ... 
0 
-20 
-80 
Pa.rtlial response 
Stable disease 
Progression 
5· pts without CT as.se.ssm:ent dre .no:f shown 
+ Co.ntin.uing tr:ealrnent 
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+ 
+ 
+ 
+ 


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Figure 2. 
Response Onset and Durability of Response (N=l 7) 
(26.1) 
. 
::::=:;;;;=:====:::·======;:::-.... 
::==::=~========-~-:===========--.... 
•. ------
::::==~===:;=t:===:::;-_,.
-:---.. 
.. 
.... 
0 
4 
8 
-
No prior CDK 4/6 
inhibitor 
-
Prior CDK 4/6 
inhibitor 
_,. Continuing 
T Onset of response 
12 
16 
Months from start of sacituzumab govitecan 
Median duration of 
response: 7.4 months 
(95% Cl: 4.4, 18.3) 
Median t ime to onset of 
response: 
2.3 months (range: 1.5-
7.8) 
7 responders were st ill 
receiving sacituzumab 
govitecan at last 
assessment 
Figure 3. 
Progression-free Survival for 54 HR+/HER2-Negative Metastatic 
Breast Cancer Subjects: Administered Sacituzumab Govitecan (ITT 
Population) 
100 
80 
--~ 
j 
60 
I:!. 
40 
1 ] 
20 
0 
0 
4 
8 
Number at risk 
49 
29 
13 
12 
Median PFS, 
months 
(95% Cl) 
16 
Months 
3 
2 
20 
24 
1 
1 
Local 
6 .8 
(4.6, 9 .3) 
28 
0 
HER2-=lmman epidenual growth factor receptor 2 negative; HR=honuonal receptor; ITI=Intent-to-Treat. 
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2.4.4.
Safety Data
The safety profile of sacituzumab govitecan has been characterized based on 420 patients 
included in the Overall Safety Population in Study IMMU-132-01. As described in 
Section 2.6, subjects were treated with doses of 8 mg/kg, 10 mg/kg, 12 mg/kg, and 18 mg/kg. 
This population included 164 patients with breast cancer (including 108 patients with metastatic 
TNBC treated with 10 mg/kg), 45 patients with urothelial cancer, 110 patients with lung cancer 
(small cell lung cancer and non-small cell lung cancer), and 101 patients with other epithelial 
cancers (including cervical, colorectal, endometrial, epithelial ovarian, esophageal, gastric, 
glioblastoma multiforme, head and neck, hepatocellular, prostate, pancreatic, and renal). As of 
01 Dec 2017, the mean treatment duration in these patients was 160 days (7.7 cycles). The 
following is a summary of the safety data; additional details can be found in the sacituzumab 
govitecan IB.
Nearly all subjects experienced at least one AE, with 75% with one ≥National Cancer Institute 
Common Terminology Criteria for AEs (NCI-CTCAE) Grade 3 AE. Overall, 41% had a serious 
AE (SAE). AEs leading to treatment interruption occurred in 48% of subjects; however, only 
11% of subjects discontinued due to an AE. Fatal AEs (within 30 days of last dose) occurred in 
6.7% of subjects; however, nearly all of these deaths were in the setting of disease progression.
The most frequent AEs were gastrointestinal (nausea, vomiting, and diarrhea) and 
myelosuppressive (neutropenia and anemia). Nausea occurred in 67% (5% ≥Grade 3); vomiting 
occurred in 44% (4% ≥Grade 3); and diarrhea occurred in 62% (9% ≥Grade 3) of patients. All 
subjects were administered prophylactic antiemetic treatments and nausea, vomiting, and 
diarrhea were managed according to standard treatment guidelines. With aggressive management 
of these toxicities, few subjects required treatment discontinuation.
The most frequent myelosuppressive AEs were neutropenia (41% overall; ≥Grade 3, 28%) and 
anemia (41% overall; ≥Grade 3, 11%). Neutrophil count decreased occurred in 18% of subjects 
(13% ≥Grade 3) and febrile neutropenia occurred in 6%. Although treatment was interrupted due 
to neutropenia in 21% of subjects, only one subject discontinued treatment because of 
neutropenia.
Infections occurred in 43% of subjects (10% ≥Grade 3); the most frequent infections were 
common, and community-acquired, such as urinary tract infections (12%) and upper respiratory 
tract infections (10%). Pneumonia occurred in 5% (3% ≥Grade 3) of subjects, sepsis in 1.4% 
(6 subjects), and septic shock in 0.5% (2 subjects).
Other frequent AEs included fatigue (53%) and alopecia (42%). Only 2 subjects had 
infusion-related hypersensitivity reactions requiring permanent discontinuation of treatment 
(anaphylaxis in one subject and wheezing, cough, and nasal congestion in a second subject). 
These subjects were ADA negative.


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As noted previously in Section 2.3, SN-38 (the active metabolite of irinotecan) is metabolized by 
UGT1A1. Irinotecan-treated subjects who are homozygous for the UGT1A1 *28 allele are at 
increased risk for neutropenia and diarrhea {CAMPTOSAR 2014}. Preliminary results from 
Study IMMU-132-01 suggest that the frequency of some exposure-related AEs (i.e., neutropenia 
and febrile neutropenia) may also be higher in subjects homozygous for the *28 allele; however, 
the frequencies of neutrophil count decreased and other treatment-related AEs, notably diarrhea, 
did not differ among homozygous compared with heterozygous subjects.
2.5.
Rationale for the Study
MBC has a high unmet medical need. Sacituzumab govitecan has been generally safe and well 
tolerated in nonclinical and clinical studies. Additionally, in a Phase 1 study in subjects with 
HR+/HER2- MBC, subjects treated with sacituzumab govitecan had an ORR of 31%, a median 
DOR of 7.4 months, with a CBR of 48% in all subjects. Taken together, these results suggest that 
sacituzumab govitecan is a promising agent for HR+/HER2- breast cancer patients. The study 
described herein will be conducted to assess and compare the efficacy and safety of sacituzumab 
govitecan to TPC in previously-treated subjects with relapsed/refractory HR+/HER2- MBC.
2.6.
Rationale for Dose Regimen
In the Phase 1 part of study IMMU-132-01, dose escalation was performed according to a 
standard 3+3 design and based on planned initial sacituzumab govitecan dose levels of 8, 12, and 
18 mg/kg. A sacituzumab govitecan dose of 12 mg/kg was formally identified as the maximum 
tolerated dose (MTD), but was associated with dose delays and reductions in several subjects. In 
order to determine a maximum acceptable dose, additional subjects were treated at the 8 mg/kg 
dose level and an intermediate dose cohort of 10 mg/kg was added. Both dose levels were shown 
to be better tolerated in the first cycle than the formally-determined MTD of 12 mg/kg, allowing 
repeated cycles with a better safety profile. Interim analyses demonstrated that subjects receiving 
the 10 mg/kg dose had a comparable treatment duration as subjects receiving 8 mg/kg. However, 
there was no worsening of AE incidence nor severity with the 10 mg/kg dose compared with the 
8 mg/kg dose. ORR and CBR were higher and PFS was longer with the 10 mg/kg dose compared 
with the 8 mg/kg dose, specifically in TNBC patients {Ocean 2017}. Based on these results, 
10 mg/kg was chosen as the dose for further study. Additional information regarding safety and 
efficacy of sacituzumab govitecan can be found in current edition of the sacituzumab govitecan 
IB.
2.7.
Risk/Benefit Assessment for the Study
An infectious disease pandemic may pose additional risks to study drug availability, the study 
visit schedule, and adherence to protocol-specified safety monitoring or laboratory assessments. 
Refer to Appendix 10 for further details on the risks and risk mitigation strategy.
2.8.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements.


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3. 
STUDY OBJECTIVES 
3.1. 
Primary Objective 
The prirmuy objective of the study is: 
Amendment 7 
• 
To assess and compare the efficacy of sacituzumab govitecan to TPC as measured by PFS as 
detennined by blinded independent central review (BICR) using RECIST 1.1 (see 
Appendix 6) in subjects with HR+/HER2- MBC who have progressed after CDK 4/6 
inhibitor, endocrine therapy, taxane, and at least 2, but no more than 4 prior chemotherapy 
regimens for metastatic disease 
3.2. 
Secondary Objectives 
The secondaiy objectives of the study ai·e: 
• 
To assess and compai·e sacituzumab govitecan to TPC in overall smvival (OS) in subjects 
with HR+/HER2- MBC who have progressed after CDK 4/6 inhibitor, endocrine therapy, 
taxane and at least 2, but no more than 4 prior chemotherapy ti·eatment regimens for 
metastatic disease 
• 
To assess and compai·e ORR, DOR, and CBR between ti·eatment anns as detennined by LIR 
and BICR using RECIST 1.1 
• 
To assess and compai·e the impact of ti·eatment on time to deterioration (TTD) of global 
health status/QOL, pain, and fatigue domains as measured by European Organization for the 
Research and Treatment of Cancer (EORTC) quality of life for cancer patients, core 
questionnaire version 3.0 (QLQ-C30) 
• 
To assess and compai·e the overall safety and tolerability 
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4.
INVESTIGATIONAL PLAN
4.1.
Overall Study Design
Study IMMU-132-09 (TROPiCS 02 [Trop-2 Investigation in Cancer with sacituzumab 
govitecan]) is an open-label, randomized, multicenter, international Phase 3 study to compare the 
efficacy and safety of sacituzumab govitecan versus TPC in subjects with metastatic or locally 
recurrent inoperable HR+/HER2- MBC who have progressed after CDK 4/6 inhibitor, endocrine 
therapy, taxane, and at least 2, but no more than 4 prior chemotherapy treatment regimens for 
metastatic disease.
Approximately 520 eligible subjects will be randomized in a 1:1 ratio to either sacituzumab 
govitecan (Investigational Arm A) or TPC (Control Arm B; i.e., eribulin, capecitabine, 
gemcitabine, or vinorelbine). Randomization will be stratified based on prior chemotherapy 
regimens for treatment of metastatic disease (two vs. three/four lines), visceral metastasis (Y/N), 
and endocrine therapy in the metastatic setting for at least 6 months (Y/N).
The study will be conducted in two phases, a Pre-randomization Phase and a Randomization 
Phase:

The Pre-randomization Phase will last no longer than 28 days and consists of the following 
two periods:
A Screening Period to establish study eligibility
A Baseline Period to confirm eligibility and establish disease characteristics prior to 
randomization and treatment

The Randomization Phase will begin at the time of randomization of the first subject and will 
end on the data cut-off date for the final analysis of OS; the Randomization Phase consists of 
the following two periods:
A Treatment Period which begins at the time of randomization and ends with the 
completion of the End-of-Treatment (EOT) visit, which will occur at least 30 days after 
the final dose of study treatment
A Follow-up Period which begins the day after the EOT visit and continues as long as the 
subject is alive or until the data cut-off date of the final analysis of OS, unless the subject 
withdraws consent from the study or the Sponsor terminates the study
4.2.
Data Safety Monitoring Committee
An independent Data Safety Monitoring Committee (DSMC) will be convened at regular 
intervals to assess the progress of this study and review safety per an approved DSMC charter.


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4.3.
End Points
4.3.1.
Efficacy
Efficacy analyses will be performed using tumor assessments by LIR and BICR using 
RECIST 1.1.
The primary efficacy end point is:

PFS as determined by BICR using RECIST 1.1
The secondary efficacy end points are:

OS 

ORR as determined by BICR using RECIST 1.1

TTD in the global health status/QOL, pain and fatigue domains of EORTC QLQ-C30 

DOR as determined by LIR and BICR using RECIST 1.1

CBR as determined by LIR and BICR using RECIST 1.1
4.3.2.
Safety
Safety and tolerability will be assessed based on the incidence of AEs and SAEs, review of 
clinical laboratory data (i.e., hematology, chemistry, and urinalysis), electrocardiogram (ECG) 
monitoring, Eastern Cooperative Oncology Group (ECOG) performance status, vital signs (i.e., 
heart rate, systolic and diastolic blood pressure, respiratory rate, and body temperature), and 
ADA.
4.4.
Duration of Study
Enrollment is expected to be completed in approximately 24 months. The overall duration of the 
study is expected to be 52 months.


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5.
SUBJECT POPULATION
5.1.
Inclusion Criteria
1) Female or male subjects, adult or aged ≥ 18 years at the time of signing the informed consent 
form (ICF)
2) Documented evidence of HR+/HER2- MBC confirmed by a local laboratory with the most 
recently available or newly obtained tumor biopsy (preferably within the last 12 months) 
from a locally recurrent or metastatic site(s) and defined per American Society of Clinical 
Oncology (ASCO)/College of American Pathologists (CAP) criteria as:
HR+ (a tumor is considered HR+ if at least 1% of the cells examined have estrogen 
and/or progesterone receptors)
HER2- defined as immunohistochemistry ≤ 2+ or fluorescence in situ hybridization 
negative
3) Availability of archival tumor tissue in a formalin-fixed, paraffin embedded (FFPE) block 
(preferably within 12 months prior to consent) or newly acquired biopsy (FFPE block) from a 
metastatic site. Note: bone biopsies are not allowed.
4) Refractory to or relapsed after at least 2, but no more than 4 prior systemic chemotherapy 
regimens for metastatic disease. Adjuvant or neoadjuvant therapy for early stage disease will 
qualify as one of the required prior chemotherapy regimens if the development of 
unresectable, locally advanced, or metastatic disease occurred within a 12-month period of 
time of the therapy. Note: treatments for bone metastases (e.g., bisphosphonates, denosumab, 
etc.) and hormonal therapy are not considered as prior systemic chemotherapy treatments for 
advanced disease
5) Should have been previously treated with:
At least 1 taxane in any setting
At least 1 prior anticancer hormonal treatment in any setting
At least 1 CDK 4/6 inhibitor in any setting.
6) Eligible for one of the chemotherapy options listed in the TPC arm.
7) Documented disease progression after the most recent therapy by computed tomography 
(CT)/magnetic resonance imaging (MRI)


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8) At least 1 measurable target lesion according to RECIST 1.1 (bony disease only is not 
allowed) meeting all of the following criteria:
Lymph node lesion that measures at least ≥ 1.5 cm in the short axis.
Non-nodal lesion that measures ≥ 1.0 cm in the longest diameter in the plane of 
measurement
The lesion is suitable for repeat measurement using computerized tomography (CT)/MRI. 
Historical CT/MRI scans performed within 28 days of C1D1 may be used as screening 
scans to demonstrate eligibility by local radiology review as long as they meet minimum 
standards as separately defined by the central imaging vendor.
Lesions that have had external beam radiotherapy (EBRT) or locoregional therapy must 
show radiographic evidence of disease progression based on RECIST 1.1 to be deemed a 
target lesion.
Brain CT/MRI must be conducted for subjects with a history of brain metastasis. The 
subject must have had stable* brain metastasis for at least 4 weeks. Target lesions cannot 
be from brain.
* Stable brain metastasis is defined as the following:
■
Prior local treatment by radiation, surgery, or stereotactic surgery.
■
Imaging – stable or decreasing size after such local treatment.
■
Clinically stable signs and symptoms for at least 4 weeks.
■
≥ 2 weeks from discontinuation of antiseizure medication
■
Low and stable doses of corticosteroids ≤ 20 mg prednisone or equivalent daily are 
permitted
9) ECOG performance status of 0 or 1
10) Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to the 
Cockcroft and Gault formula
11) Adequate bone marrow function, defined as:
Absolute neutrophil count (ANC) ≥ 1,500 per mm3
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000 per mm3
Note: Blood transfusion or growth factor support is not allowed within 14 days prior to 
screening labs.


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12) Adequate liver function, defined as:
Total bilirubin ≤ 1.5× institutional upper limit of normal (IULN) or ≤ 3 IULN for patients 
with documented Gilbert’s syndrome
Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5× IULN (in 
the case of liver metastases ≤ 5× IULN), and serum albumin ≥ 3 g/dL
Alkaline phosphatase (ALP) ≤ 5.0× IULN unless there are bone metastases, in which 
case liver-specific ALP must be separated from the total and used to assess liver function 
instead of total ALP
13) Resolution of all systemic anticancer therapy-related or radiation-related toxicities to Grade 1 
severity or lower, except for neuropathy (≤Grade 2) and alopecia. Subjects with Grade 2 
neuropathy are eligible, but should not receive vinorelbine as TPC.
14) Females must not be lactating or pregnant at Baseline (as documented by a negative beta 
human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG]) test with a 
minimum sensitivity of 25 IU/L or equivalent units of β-hCG [or hCG]). All females will be 
considered to be of childbearing potential unless they are postmenopausal (amenorrhoeic for 
at least 12 consecutive months, in the appropriate age group, and without other known or 
suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total 
hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
15) Females of childbearing potential must not have had unprotected sexual intercourse within 
30 days before study entry and must agree to use a highly effective method of contraception 
(total abstinence [if it is her preferred and usual lifestyle], a contraceptive implant, an oral 
contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the 
entire study period and for 6 months after study drug discontinuation. For sites outside of the 
European Union (EU), it is permissible that if a highly effective method of contraception is 
not appropriate or acceptable to the subject, then the subject must agree to use a medically 
acceptable method of contraception, i.e., double barrier methods of contraception such as 
condom plus diaphragm or cervical/vault cap with spermicide. If currently abstinent, the 
subject must agree to use a highly effective method as described above if she becomes 
sexually active during the study period or for 6 months after study drug discontinuation. 
Females who are using hormonal contraceptives must have been on a stable dose of the same 
hormonal contraceptive product for at least 28 days before dosing and must continue to use 
the same contraceptive during the study and for 6 months after study drug discontinuation
16) Male subjects who are partners of women of childbearing potential must use a condom and 
spermicide and their female partners, if of childbearing potential, must use a highly effective 
method of contraception (see methods described above in Inclusion Criterion 15)) beginning 
at least 1 menstrual cycle prior to starting study drug, throughout the entire study period, and 
for 3 months after the last dose of study drug, unless the male subjects are totally sexually 
abstinent or have undergone a successful vasectomy with confirmed azoospermia or unless 
the female partners have been sterilized surgically or are otherwise proven sterile.


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17) Must be willing and able to comply with all aspects of the protocol
18) Must voluntarily agree to provide written informed consent
19) Could have received an unlimited number of prior endocrine, biological, or targeted therapies 
in the absence of co-administered chemotherapy; all of these therapies must have been 
completed 14 days prior to randomization, except biological therapy which must have been 
completed 28 days prior to randomization
5.2.
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from the study:
1) Previous treatment with a topoisomerase 1 inhibitor as a free form or as other formulations
2) Current enrollment in another clinical study or used any investigational device or drug either 
within 5 half-lives or 28 days prior to randomization, whichever is longer
3) Treatment with chemotherapy, radiation, or small molecule targeted therapy within 2 weeks 
and biological therapy within 4 weeks prior to the first dose of study treatment
4) Existing anticancer treatment-related AEs of Grade ≥ 2 (except for alopecia and Grade 2 
neuropathy) according to NCI-CTCAE v5.0
5) Any other malignancy that required treatment or has shown evidence of recurrence (except 
for non-melanoma skin cancer or histologically-confirmed complete excision of carcinoma in 
situ) during the 5 years prior to enrollment in this study
6) History of significant cardiovascular disease, defined as:
Congestive heart failure greater than New York Heart Association (NYHA) Class II 
according to the NYHA Functional Classification
Unstable angina or myocardial infarction within 6 months before enrollment
Serious cardiac arrhythmia
7) Clinically-significant ECG abnormality, including any of the following:
Marked Baseline prolonged QT/QTc interval (i.e., a repeated demonstration of a QTc 
interval > 500 ms) demonstrated on ECG at Screening. QTcF is calculated by Fridericia's 
formula
,Q 
F "" 
QT 


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History of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family 
history of long QT Syndrome)
8) Has known active central nervous system metastases and/or carcinomatous meningitis. 
Subjects may participate provided they have stable brain metastasis. All subjects with 
carcinomatous meningitis are excluded regardless of clinical stability. Stable brain metastasis 
is defined in inclusion criterion 8)
9) Active hepatitis B virus (positive hepatitis B surface antigen) or active hepatitis C virus 
(measurable viral ribonucleic acid (RNA) load with polymerase chain reaction) infection
10) Scheduled surgery during the study, other than minor surgery which would not delay study 
treatment
11) Has an active serious infection requiring antibiotics
12) Has active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) and 
subjects with a history of bowel obstruction
13) Have received a live vaccine within 30 days of randomization.
14) Known hypersensitivity or intolerance to any of the study drugs or any of the excipients
15) Any medical or other condition which, in the opinion of the Investigator, causes the subject 
to be medically unfit to receive sacituzumab govitecan or unsuitable for any other reason
16) Is receiving any medication prohibited in combination with the study treatment(s) as 
described in the respective product labels, unless medication was stopped within 7 days prior 
to randomization
17) Locally-advanced MBC (stage IIIc) in subjects who are candidates for curative intent therapy 
at the time of study enrollment
18) If required per local guidelines, any subject with a blood uracil level ≥ 150 ng/mL is 
excluded from receiving capecitabine as TPC (Note: blood uracil level will be assessed at 
Screening for all subjects eligible to be randomized to capecitabine as TPC)
5.3.
Number of Subjects and Treatment Assignment
Approximately 520 subjects will be enrolled and randomized in a 1:1 ratio to receive either 
sacituzumab govitecan or a preselected TPC using an Interactive Web-Based Response System 
(IWRS), with stratification by number of prior chemotherapy regimens for treatment of 
metastatic disease (two vs. three/four lines), visceral metastasis (Y/N), and endocrine therapy in 
the metastatic setting for at least 6 months (Y/N).


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5.4.
Criteria for Removal from Study Treatment
A subject will remain on study treatment until one or more of the following events occur(s):

Unacceptable study drug-related AEs (see Section 6.1.7)

Subject request

First documentation of PD or symptomatic deterioration, indicating treatment failure in the 
absence of clinical benefit

Note: Subjects will be permitted to continue in the Treatment Period beyond initial 
RECIST 1.1-defined progression as long as investigator-assessed clinical benefit is observed 
and the subject is tolerating study drug. Subjects will discontinue study treatment upon 
evidence of further progression and/or loss of clinical benefit as judged by the Investigator.

Treatment delay for any reason > 3 weeks

Withdrawal of consent

Termination of the study by the Sponsor

Pregnancy

Investigator decision

Death

Lost to follow-up


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6.1. 
6.1.1. 
TREATMENT OF SUBJECTS 
Investigational Product, Dosage, and Mode of Administration 
Description 
Amendment 7 
Sacituzumab govitecan is fonnulated as a sterile, non-pyrogenic, lyophilized powder consisting 
of 10 mg/mL sacituzumab govitecan in 25 mM MES, pH 6.5, together with the excipients 25 
mM trehalose and 0.01 % Polysorbate 80. The fo1mulated dmg product contains no preservative. 
Sacituzumab govitecan is supplied in a 50-mL clear glass vial. 
6.1.2. 
Packaging and Labeling 
Sacituzumab govitecan will be supplied in individual cartons, each containing 1 vial. 
Study dmg(s) to be distributed to centers in the US and other pa1ticipating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guideline to Good Manufacturing 
Practice - Annex 13 (Investigational Medicinal Products), and/or other local regulations. 
- -
6.1.4. 
Preparation 
Refer to the Phannacy Manual for instmctions on preparing sacituzumab govitecan. 
6.1.5. 
Premedications 
Premedications for prevention of infusion related reactions should be administered before each 
sacituzumab govitecan infusion, including antipyretics and Hl and H2 blockers. Co1ticosteroids 
(hydroco1tisone 50 mg or equivalent orally [PO] or IV) may be administered prior to subsequent 
infusions if the subject has experienced an infusion-related reaction with a previous infusion. 
Sacituzumab govitecan is considered to be moderately emetogenic and premedication with a 
two-dmg antiemetic regimen is recommended. If nausea and vomiting are persistent, a 
three-diug regimen, including a 5-HT3 inhibitor (ondansetron or palonosetron, or other agents 
according to local practices), an NKl-receptor antagonist (fosaprepitant or aprepitant), and 
dexamethasone (10 mg PO or intravenously [IV]), may be used. Anticipato1y nausea can be 
treated with olanzapine. 
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6.1.6.
Administration
Sacituzumab govitecan is administered at 10 mg/kg as an IV infusion on Days 1 and 8 of a 
21-day cycle. Dosing is based on the subject’s body weight on Day 1 of each cycle (or at each 
dosing day if change in body weight is >10% from last measurement or if required by 
institutional policy). Dose modifications for changes in body weight ≤ 10% may be made 
according to local institutional guidelines.
Do not administer as an IV push or bolus. Sacituzumab govitecan is administered IV as a slow 
infusion as described below.
Intravenous access must be well established prior to initiating infusion. At the time of dosing, the 
IV line will be connected to an infusion container containing the prepared volume of 
sacituzumab govitecan. Either gravity or an infusion pump may be used. Only normal saline 
should be used as the infusion base solution since the Sponsor has not examined the 
compatibility of sacituzumab govitecan with other infusion diluents.
Initiate the infusion within 1 hour of reconstitution/dilution. If infusion is delayed beyond 1 hour, 
refrigerate at 2-8°C for no more than 4 hours from reconstitution/dilution prior to infusion. Once 
reconstituted and diluted into the IV bag, a paper sleeve should be put over the IV bag during 
administration or if stored at 2-8°C to protect from light until administered to the subject. If 
refrigerated, allow the diluted solution to come to room temperature prior to administration. If 
infusion is not initiated within 4 hours after reconstitution/dilution, dispose of the original 
preparation and prepare a new infusion bag by reconstituting and diluting from new vials. 
Discard any unused portion in the vial.
The initial infusion should proceed over 3 hours. Subsequent infusions can either be 
administered over 3 hours or 1-2 hours if vital signs remain stable and no infusion reactions 
occur. Monitor the patient during and for at least 30 minutes after infusion. Following infusion 
completion, the IV line should be flushed slowly with 20 mL normal saline and the 
end-of-infusion time recorded. In the event of infusion reactions or vital sign changes, the 
infusion rate may be slowed, interrupted, or terminated as considered appropriate by the 
managing physician.
6.1.7.
Management of Sacituzumab Govitecan Toxicity
Section 6.1.7.1 provides guidance for modification of the sacituzumab govitecan dose and 
discontinuation for management of toxicity. Section 6.1.7.2 provides guidance on the 
management of toxicities known to occur with sacituzumab govitecan. Toxicities should be 
managed in accordance with standard institutional practices and accepted treatment guidelines.


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6.1.7.1.
Dose Delays, Dose Reductions, and Study Drug Discontinuations
Dose Delays
Sacituzumab govitecan is to be administered in 21-day cycles on Day 1 and Day 8; the next 
cycle should start a minimum of 14 days after the Day 8 dose. Visit windows of ±2 days from the 
scheduled infusion are permitted. Scheduled Day 1 dosing may be delayed for up to 1 week for 
treatment-related toxicities. Instructions for dose delays and dose reductions for specific 
toxicities are summarized below. Day 8 dosing could be delayed for up to 1 week for 
treatment-related toxicities, however, if the toxicity has not resolved to ≤Grade 2 within 1 week 
of Day 8, then the scheduled Day 8 dosing may be cancelled and dosing should resume with the 
Day 1 of the following cycle. There should be a minimum of 14 days and a maximum of 21 days 
between the Day 8 infusion and the Day 1 infusion of the next cycle. No other treatment 
interruptions are permitted.
Dose Reductions and Discontinuation
The major toxicities of sacituzumab govitecan are expected to be gastrointestinal symptoms and 
hematologic suppression. All subjects will be closely monitored over the course of their 
treatment and aggressively medically managed, including dose reduction and interruption, in 
order to prevent the need for treatment discontinuation and serious complications from these 
toxicities. Sacituzumab govitecan dose reductions and interruptions will be managed based on 
toxicity severity assessed by NCI-CTCAE v5.0. The sacituzumab govitecan dose must not be 
re-escalated following a dose reduction. Table 5 summarizes recommendations for sacituzumab 
govitecan dose reductions and discontinuations for treatment-related toxicities.


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Table 5.
Recommended Dose Reduction Schedule for Sacituzumab Govitecan 
Event
NCI-CTCAE v5.0 
Occurrence
Recommended dose 
reduction or action
Severe Neutropenia
First
Administer 
granulocyte-colony 
stimulating factor or sooner, 
if clinically indicated
Second
25% dose reduction
Third
50% dose reduction
Grade 4 neutropenia ≥ 7 days,
OR
Grade 3-4 febrile neutropenia 
OR
At time of scheduled treatment, ≥Grade 3 neutropenia which 
has delayed dosing by 1 week 
Fourth
Discontinue treatment
 ≥Grade 3 neutropenia which delays dosing beyond 3 weeks
First
Discontinue treatment
Severe Non-Neutropenic Toxicity
First
25% dose reduction
Second
50% dose reduction
Grade 4 non-hematologic toxicity of any duration,
OR
Any ≥Grade 3 nausea, vomiting or diarrhea due to treatment 
that is not controlled with antiemetics and anti-diarrheal agents,
OR
Other ≥Grade 3 non-hematologic toxicity persisting >48 hours 
despite optimal medical management,
OR
At time of scheduled treatment, ≥Grade 3 non-neutropenic 
hematologic or non-hematologic toxicity, which has delayed 
dosing by 1 week
Third
Discontinue treatment
≥Grade 3 non-neutropenic hematologic or non-hematologic 
toxicity, which has delayed dosing for more than 3 weeks
First
Discontinue treatment
6.1.7.2.
Management of Specific Toxicities
6.1.7.2.1.
Infusion-Related Reactions
Infusion-related reactions can occur at any cycle and are defined as symptoms that occur during 
and within the first 6 hours after the infusion of sacituzumab govitecan. Symptoms can include 
fever, chills, rigors, arthralgias, myalgias, urticaria, pruritus, rash, diaphoresis, hypotension, 
dizziness, syncope, hypertension, dyspnea, cough, and wheezing, as well as severe 
hypersensitivity reactions, including anaphylactic reactions. Infusion-related reactions should be 
treated in accordance with best clinical practices and standard institutional guidelines. Because 
of the potential for life threatening infusion-related reactions, sacituzumab govitecan should only 
be administered in a setting in which appropriately trained medical staff, emergency equipment, 
and medications are available in the event that resuscitation is required. NCI-CTCAE v5.0 is 
used to grade the severity of all infusion-related AEs. Premedication for the prevention of 
infusion related-reactions is described in Section 6.1.5.


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Grade 3 and Grade 4 Events
Grade 3 and Grade 4 infusion-related reactions can include severe or clinically-significant 
cardiopulmonary events and severe allergic reactions, such as symptomatic bronchospasm and 
anaphylactic reactions. Grade 3 infusion-related reactions are defined as those which are 
prolonged and do not improve with symptomatic treatment and/or brief interruption of treatment; 
reactions that recur following treatment; and reactions that require hospitalization. Grade 4 
reactions include potentially life-threatening reactions requiring urgent intervention. Severe 
allergic and anaphylactic reactions should be treated in accordance with best clinical practices 
and standard institutional guidelines. If Grade 3 or Grade 4 infusion-related reactions occur, 
sacituzumab govitecan should be permanently discontinued.
Grade 2 Events
Grade 2 infusion-related reactions are defined as those that require infusion interruption and 
respond to symptomatic treatment; prophylactic medications are indicated for ≤ 24 hours. For 
Grade 2 infusion-related reactions, the infusion should be interrupted for at least 15 minutes until 
symptoms resolve. After symptoms resolve, the infusion should be resumed at a slower infusion 
rate. Recommended infusion rates are provided in Section 6.1.6. For recurrent Grade 2 infusion 
reactions that fail to recover within 6 hours, despite optimal management, sacituzumab govitecan 
should be permanently discontinued.
6.1.7.2.2.
Gastrointestinal Toxicities
Nausea, vomiting, and diarrhea are frequent sacituzumab govitecan-associated toxicities. 
Appropriate treatment, including, as needed, fluid and electrolyte replacement, is required to 
minimize the risk of serious consequences such as dehydration. Instructions for sacituzumab 
govitecan dose reduction for treatment-related gastrointestinal toxicities are provided in 
Section 6.1.7.2.2.
Nausea and Vomiting
Instructions for the use of premedications for prophylactic treatment of nausea and vomiting and 
anticipatory nausea are provided in Section 6.1.5. Do not hold the dose of sacituzumab govitecan 
for Grade 3 nausea unless Grade 3 nausea persists despite maximal optimal medical 
management. Subjects should be treated for delayed nausea and vomiting on Days 2 and 3 with 
5-HT3 receptor antagonist (ondansetron or palonosetron) monotherapy and other agents if 
needed. Steroids may be added if symptoms do not resolve with these agents. Consider 
olanzapine for persistent or anticipatory nausea; an olanzapine dose of 2.5 mg or 5 mg at bedtime 
is recommended. NK1 receptor antagonists (fosaprepitant and aprepitant) may be administered.


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Diarrhea
Dietary modification should be recommended for the management of diarrhea, including a bland 
diet, small frequent meals, adequate fluid intake of clear liquids to maintain hydration, and 
discontinuation of lactose-containing foods and drinks containing alcohol. Loperamide should be 
administered at the onset of treatment-related diarrhea at an initial dose of 4 mg, followed by 
2 mg with every episode of diarrhea to a maximum dose of 16 mg/day. If diarrhea is not resolved 
after 24 hours, add diphenoxylate/atropine or opium tincture as clinically indicated. Add 
octreotide 100-150 μg subcutaneously 3 times per day if diarrhea persists. For Grade 4 diarrhea, 
consider subject hospitalization and treatment with IV fluids and octreotide. Antibiotics can be 
administered as clinically indicated.
Subjects who exhibit an excessive cholinergic response to treatment with sacituzumab govitecan 
(e.g., abdominal cramping, diarrhea, salivation, etc.) can receive appropriate premedication (e.g., 
atropine) for subsequent treatments.
6.1.7.2.3.
Neutropenia
Complete blood counts must be obtained prior to each sacituzumab govitecan infusion and 
should be administered if ANC meet the following criteria:

Day 1: ANC ≥ 1500/mm3

Day 8: ANC ≥ 1000/mm3
The routine prophylactic use of growth factors is not recommended; however, they may be used 
in subjects who have experienced febrile neutropenia or Grade 3 or Grade 4 neutropenia 
following previous infusions. Growth factors may also be administered in the setting of 
neutropenia in subjects at high risk of poor clinical outcomes, including those with prolonged 
neutropenia, ANC < 1000/mm3, febrile neutropenia, and serious infections.
6.1.8.
Drug Interactions
No formal drug-drug interaction studies with sacituzumab govitecan have been conducted. 
SN-38 (the active metabolite of sacituzumab govitecan) is metabolized via human UGT1A1. 
Concomitant administration of inhibitors or inducers of UGT1A1 with sacituzumab govitecan 
should be avoided due to the potential to either increase (inhibitors) or decrease (inducers) the 
exposure to SN-38.
UGT1A1 Inhibitors
Co-administration of sacituzumab govitecan with inhibitors of UGT1A1 (e.g., atazanavir, 
gemfibrozil, indinavir) may increase systemic exposure to the active metabolite, SN-38. Do not 
administer UGT1A1 inhibitors with sacituzumab govitecan unless there are no therapeutic 
alternatives.


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UGT1A1 Inducers
Exposure to SN-38 may be substantially reduced in subjects concomitantly receiving UGT1A1 
enzyme inducers. Do not administer UGT1A1 inducers with sacituzumab govitecan unless there 
are no therapeutic alternatives.
6.1.9.
Drug Accountability and Destruction
Study drug must be stored under refrigerated conditions (2-8ºC) in a locked room that can be 
accessed only by the pharmacist, the study Investigator, or another duly authorized study/site 
personnel. Study medication must not be used outside of the context of this protocol. Under no 
circumstances should the Investigator or other site personnel supply study drug to other 
Investigators, subjects, or clinics or allow supplies to be used other than as directed by this 
protocol. Records documenting receipt, use, return, loss, or other disposition of study drug vials 
must be kept. A complete drug accountability record supplied by the Sponsor (or its designee or 
National Cancer Institute drug accountability forms) or computer records used by the pharmacy 
at the investigational site can be used to provide drug accountability. In all cases, information 
describing study medication disposition, subject-by-subject, must be provided and signed by the 
Investigator (or the pharmacist or other person who dispensed the drug) and collected by the 
Study Monitor. Requisite data include relevant dates, quantities, batches or code numbers, and 
subject identification for subjects who received trial product. At the end of the study, following 
authorization by the Study Monitor, study medication may be destroyed at the site as dictated by 
the appropriate standard operating procedures at the participating sites. Destruction must be 
documented with the signature of either the site’s pharmacist or delegate. Alternatively, after 
notification, all unused product will be collected by the Study Monitor and returned to the 
Sponsor or its designee.
If abnormalities of the drug vial, reconstituted product, or specific AEs are noted that are thought 
to be attributed to study drug, under no circumstances are additional testing or procedures to be 
performed on the affected study drug vial or infusion bag and study drug should not be 
discarded. Entire study drug should be retained at the site and the Sponsor or Sponsor’s 
representative should be immediately notified. Please refer to the Laboratory Manual for further 
instructions.
6.2.
Treatment of Physician’s Choice
TPC is single-agent treatment determined before randomization from one of the following:

Eribulin - (1.4 mg/m2 for North American sites, 1.23 mg/m2 for EU sites or per institution) is 
to be administered IV on Days 1 and 8 of a 21-day cycle

Capecitabine - (1000-1250 mg/m2) is to be administered PO twice daily for 2 weeks followed 
by a 1-week rest period given as a 21-day cycle

Gemcitabine - (800-1200 mg/m2) administered IV on Days 1, 8, and 15 of each 28-day cycle 
or per institution


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
Vinorelbine (25 mg/m2 IV on Day 1 weekly cycle per institution) (Note: subjects with grade 
2 neuropathy are eligible, but should not receive vinorelbine as TPC)
No combination or crossovers of the 4 choices is permitted.
The use of premedications (i.e., antipyretics, H1 blockers, and H2 blockers) for prevention of 
infusion reactions and medications for prevention and treatment of chemotherapy-induced 
nausea, vomiting, and diarrhea for subjects in this group is based on the Investigator’s discretion.
TPC dosing is based upon body surface area as per local standard of care and should be 
administered using the recommended doses and schedules in the locally-approved prescribing 
information or according to NCCN guidelines (with dose/schedule modifications either 
according to locally-approved prescribing information or institutional standard practices; 
https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf).
6.3.
Concomitant Medications and Procedures
Medications initiated prior to the first dose of study drug will be recorded as prior medications 
and medications initiated following receipt of the first dose of study drug until 30 days after 
treatment discontinuation will be captured as concomitant medications. Medication information 
will be entered in the appropriate electronic Case Report Form (eCRF) with information 
regarding dose, indication, route of administration, and dates of administration. Medications used 
for prophylaxis of anticipated AEs should be documented with the rationale for prophylactic 
intent (see Section 6.1.5).
6.3.1.
Prohibited Concomitant Medications and Procedures
Subjects are prohibited from receiving the following therapies during the Pre-Randomization 
Period (Baseline/Screening) and Treatment Period of this study:

Anticancer therapies: No anticancer therapies, aside from study drug, are permitted during 
this study

Radiation therapy: Radiation therapy is prohibited within 2 weeks prior to randomization.
Note: Radiation therapy to a symptomatic solitary non-target lesion or to the brain may be 
allowed while on study treatment after consultation with Sponsor provided that palliative 
radiotherapy is not indicated for tumor progression. Such radiation therapy would be 
considered a progression event in efficacy analyses.

High-dose systemic corticosteroids are not allowed within 2 weeks of randomization. Low 
and stable doses of corticosteroids ≤ 20 mg prednisone or equivalent daily are permitted if 
the subject entered the study on low-dose steroids for treated brain metastasis or if medically 
indicated as part of premedication for infusions. (Topical steroids and corticosteroid inhalers 
are allowed)

Herbal supplements are not recommended


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6.3.2.
Permitted Concomitant Medications and Procedures
Palliative and/or supportive medications, such as pain medications, bone-modifying medications 
(bisphosphonates or denosumab), anti-emetics or anti-diarrheal medications, transfusions and 
growth factor support, continuing or initiating the use of low-dose corticosteroids, and other 
palliative medications for complications of disease, including medications for pain and dietary 
support, are allowed at the Investigator’s discretion. Palliative external radiotherapy is permitted, 
but presence of new or worsening metastases will be considered progression.
There is not substantial safety data regarding the concurrent administration of the coronavirus 
disease 2019 (COVID-19) vaccine and sacituzumab govitecan. Patients are allowed to receive 
the COVID-19 vaccine to reduce the risk and complications of COVID-19 infection. The study 
visits should continue as planned if possible, and clinically appropriate if vaccination occurs 
while the patient is on the study.
6.3.3.
QT-Prolonging Drugs
Subjects receiving QT-prolonging drugs should be carefully monitored as some of the study 
medications may increase the QT interval. When possible, the Investigator should consider 
avoiding these medications and using alternative medications that do not affect the QT interval. 
While 5-HT3 receptor antagonist compounds can prolong the QT interval, they are effective for 
prophylaxis/treatment of nausea associated with sacituzumab govitecan and investigators are 
advised to monitor subjects closely when used. See Appendix 8 for a list of medications that 
affect the QT interval.


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7.
STUDY PROCEDURES
7.1.
Informed Consent
No study-specific study procedure or alteration of subject care will be undertaken until informed 
consent has been obtained either from the subject or his/her legally authorized representative. 
The Investigator will explain the nature and scope of the study, potential risks and benefits of 
participation, and answer questions for the subject and/or legally authorized representative.
If the subject agrees to participate, the ICF must be signed, dated, and witnessed, with a copy 
given to the subject. The consenting process must be well documented by each investigational 
site.
If the subject decides to stop all protocol procedures and withdraw consent for treatment, the 
subject will be asked to sign an additional ICF for the collection of follow-up information 
regarding further lines of therapy and survival.
If a subject is allowed to continue treatment after progression, the subject will be required to sign 
an additional ICF to ensure awareness that he/she is foregoing other therapies, including other 
clinical trials that may be available.
7.2.
Subject Registration
At such time as a subject has been deemed eligible for the study and all required screening 
evaluations have been completed, the subject can be randomized using the IWRS.
Randomization must occur on or before C1D1, such that dosing commences within 5 days after 
randomization.
7.3.
Demographics, Medical History, Prior and Concomitant Medications
Each subject’s demographic and medical/surgical history, all prior anti-cancer treatments, 
including treatment response and also time to progression for last therapy regimen (if available), 
and all prior therapies are to be collected within 28 days prior to randomization. Mutational 
status, including breast cancer susceptibility gene 1 and 2, will also be collected, if known.
All prior and concomitant medications (including over-the-counter medicines, herbal treatments, 
supplements, vitamins, and substance use) and treatments taken from 28 days prior to signing 
consent until at least 30 days after the last dose of study drug will be recorded.


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7.4.
Tumor Assessments
7.4.1.
Screening
Target and non-target lesions must be determined by the clinical site at the time of 
randomization. Note: brain lesions cannot be target lesions.

Screening tumor assessments using CT/MRI of the chest, abdomen, and pelvis and other 
areas of known disease or newly suspected disease should be performed within 28 days prior 
to C1D1
Scans of the abdomen, pelvis, and other areas of the body may be done with MRI instead 
of CT, but evaluation of the chest should be done with CT. CT scans should be performed 
with oral and iodinated IV contrast and MRI scans with IV gadolinium chelate unless 
there is a medical contraindication to contrast
Historical CT/MRI scans performed within 28 days before C1D1 may be used as 
screening scans to demonstrate eligibility by local radiology review as long as they meet 
minimum standards as separately defined by the central imaging vendor

A bone scan (99m-technetium polyphosphonate scintigraphy, whole body bone MRI, or 
18F-NaF/FDG PET) to assess bone metastases will be performed within 6 weeks prior to 
C1D1 (historical scans are acceptable)

Brain CT/MRI in subjects with known or suspected brain metastases. Historical brain 
CT/MRI scans performed within 28 days before C1D1 may be used as screening scans to 
demonstrate eligibility, as long as they meet minimum standards as separately defined by the 
central imaging vendor

Histology or cytology review locally to confirm HR+/HER2- MBC according to ASCO/CAP 
criteria

Tumor sample from either an FFPE archival block (preferably within 12 months prior to 
consent) or a newly acquired biopsy are to be sent to the Sponsor’s designee for assessment 
of Trop-2 expression. A newly-acquired biopsy cannot be taken from any target lesion being 
used for tumor assessments. Alternatively, a minimum of 6 freshly sectioned unstained slides 
of archived biopsy/surgical specimens (outlined above) may be submitted. Tumor blocks 
may be returned to the clinical site after being processed, if requested.


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7.4.2.
CT or MRI Tumor Assessments
Tumor assessments during the study should use the same methodology (CT or MRI) and scan 
acquisition techniques (including use or non-use of IV contrast) as used for the screening 
assessments. Tumor assessments will be performed by LIR and BICR review of CT/MRI scans 
using RECIST 1.1 (Appendix 6). Tumor assessments during the study include:

CT or MRI tumor assessments of the chest, abdomen, pelvis and other areas where scans 
were performed at screening or of sites with newly suspected disease should be performed 
every 6 weeks ±1 week after the start of study treatment (or sooner if there is evidence of 
PD) through 54 weeks then every 12 weeks ±1 week until the occurrence of progression of 
disease as determined by LIR using RECIST 1.1. Assessment intervals should not be 
changed in case of delays in dose administration.

Bone scans (99m-technetium polyphosphonate scintigraphy, whole body bone MRI, or 
18F-NaF/FDG PET) will be performed during the Treatment Period if clinically indicated 
and within a target of 1 week, but no more than 2 weeks after a subject achieves a CR to 
exclude new bone metastases. The same bone scan methodology and acquisition techniques 
used at screening should be used throughout the study to ensure comparability. Lesions 
detected on bone scans must be followed with cross-sectional imaging.

Brain CT/MRI in subjects with known brain metastases. During the Treatment Period, 
CT/MRI of the brain will be performed if clinically indicated and within a target of 1 week 
after a subject achieves a CR. For subjects with history of treated brain metastases, brain 
scans will be performed at tumor assessment time points if clinically indicated. The same 
methodology and scan acquisition techniques used at screening should be used throughout 
the study to ensure comparability.
Investigator-determined response assessments will be performed at each assessment time point 
and entered onto the eCRF. Copies of all tumor assessment scans, as well as any unscheduled 
scans, will be sent to the central imaging vendor designated by the Sponsor. Tumor assessments 
will be carried out following the guidelines provided by the central imaging vendor.
In most cases, disease progression will be based on LIR using RECIST 1.1 criteria. If disease 
progression is based on the subject’s symptoms, every effort should be made to document 
progression using objective criteria.
7.5.
Quality of Life
HRQOL will be assessed prior to study drug administration and before other assessments and 
procedures (see Appendix 4) using the following subject questionnaires:

EORTC QLQ-C30, 30-item instrument assesses 15 scales:
Global health status/Quality of Life scale;


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Five functional scales: physical, role, cognitive, emotional, and social; and
Nine symptom/item scales: fatigue, nausea and vomiting, pain, dyspnea, insomnia, 
appetite loss, constipation, diarrhea, and financial difficulties.

EQ-5D-5L, health status instrument comprised of 2 parts:
The descriptive system with which patients rate the severity of their experience in 
5 dimensions (mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression) along 5 levels of severity. A utility value for each health state is 
assigned on the basis of a set of preference weights (tariffs) elicited from the general 
population and is specific for each country; and
The EQ-5D visual analogue scale (EQ-VAS) for patients to self-rate their health state.

PRO-CTCAETM, subjects will be asked about 9 selected symptoms, based on the previously 
reported AE profile for TPC and sacituzumab govitecan, including decreased appetite, 
nausea, vomiting, constipation, diarrhea, abdominal pain, shortness of breath, hair loss, and 
fatigue. Responses are scored from 0 to 4 with no standardized scoring rules
See Appendix 5 for each of the questionnaires.
7.6.
Assessment of Safety
7.6.1.
Physical Examinations
A full physical examination and total body examination of all major body systems (e.g., general 
appearance, skin, neck [including thyroid], ears, eyes, nose, throat, lungs, heart, abdomen, back, 
lymph nodes, and extremities and a clinical neurological examination), and weight must be 
performed. Post-screening physical examinations may be targeted based on findings present at 
screening or subject complaints (see Appendix 4).
Clinically-significant physical examination findings at screening should be recorded either as 
medical history or as an AE as appropriate. Clinically-significant new findings at post-screening 
visits should be recorded as AEs.
7.6.2.
Vital Signs
Vital signs, including heart rate, systolic and diastolic blood pressure, respiratory rate, and body 
temperature, will be measured throughout the study (see Appendix 4).
7.6.3.
ECGs
Standard 12-lead ECGs will be recorded throughout the study (see Appendix 4) and at additional 
time points if clinically indicated.


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7.6.4.
Laboratory Assessments
Blood and urine will be collected for analysis of the laboratory parameters specified in Table 6 
according to the Schedule of Assessments (see Appendix 4).
Table 6.
Laboratory Assessments
Hematology
Complete blood count including platelet count, with white blood cell differential in 
absolute cell counts
Chemistry
Glucose, creatinine, BUN1, total bilirubin, ALT, AST, lactate dehydrogenase, ALP, 
creatinine clearance2, serum albumin, total protein, sodium, potassium, calcium, chloride, 
magnesium phosphorus, and blood uracil level3 
Urinalysis
Glucose, ketones, pH, protein, white blood cells, hemoglobin (or red blood cells), and 
specific gravity. Microscopic examination if there are positive findings for blood, protein, 
leukocytes, or nitrite on the dipstick analysis4 
Others
Serum HCG tests (women of childbearing potential only), hepatitis B surface antigen 
test, hepatitis C (either antibody test or viral testing)
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea nitrogen.
1
Sites that do not perform BUN testing can calculate BUN from urea using the following standard formula: 
BUN (mg/dL) = Urea (mg/dL)/2.1428.
2
May be calculated using Cockcroft-Gault equation.
3
Drawn at Screening if required by local guidelines on all subjects eligible to be randomized to the TPC capecitabine arm in 
order to exclude subjects from receiving TPC capecitabine if blood uracil level is ≥ 150 ng/mL.
4
If urinalysis suggests a urinary tract infection or if clinically indicated, culture and sensitivity should be performed at the 
institution’s laboratory.
7.6.5.
ECOG Performance Status
ECOG performance status (Appendix 2) will be assessed per the Schedule of Assessments (see 
Appendix 4).
7.6.6.
Adverse Events and Serious Adverse Events Reporting
All subjects must be carefully monitored for AEs, including SAEs (defined in Section 7.6.6.1 
and Section 7.6.6.2). Sufficient information must be obtained by the Investigator to determine 
whether the event meets criteria for immediate reporting to the Sponsor (i.e., SAEs and 
pregnancies). All AEs should be assessed in terms of their seriousness (Section 7.6.6.2), severity 
(Section 7.6.6.7), and relationship to the study drug (Section 7.6.6.8).
7.6.6.1.
Definition of an Adverse Event
An AE is defined as any untoward medical occurrence in a subject administered a medicinal 
product that does not necessarily have a causal relationship with this treatment. Therefore, an AE 
can be any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of an investigational product, whether or 
not related to the investigational medicinal product.


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AEs may include worsening or exacerbation of preexisting conditions or events; intercurrent 
illnesses; or drug interactions.
An AE does not include the following:

Medical or surgical procedures such as surgery, endoscopy, tooth extraction, or transfusion. 
The condition that led to the procedure may be an AE and must be reported.

Preexisting diseases, conditions, or laboratory abnormalities present or detected before the 
screening visit that do not worsen. Anticipated fluctuations of preexisting conditions that do 
not represent a clinically significant exacerbation or worsening are not considered AEs.

Situations where an untoward medical occurrence has not occurred (e.g., hospitalization for 
elective surgery, social and/or convenience admissions).

Overdose without clinical sequelae.

Any medical condition or clinically significant laboratory abnormality with an onset date 
before the informed consent form is signed and not related to a protocol-associated procedure 
is not an AE but rather considered to be preexisting and should be documented as medical 
history.
Preexisting events that increase in severity or change in nature after study drug initiation or 
during or as a consequence of participation in the clinical study will also be considered AEs.
In this protocol, disease progression is an efficacy end point and should not be reported as an 
AE. It is important to differentiate expected disease progression from an AE. Events that are 
clearly consistent with the expected pattern of disease progression should not be considered AEs. 
Expected disease progression refers to an event that is unequivocally related to disease 
progression and has a clinical course consistent with what would be expected for the subject’s 
disease. A clinical event in the setting of disease progression would be considered an AE if it 
could not be unequivocally attributed to or is inconsistent with expected disease progression.
AEs should be recorded using medical terminology and, whenever possible, a diagnosis should 
be provided for clearly associated signs, symptoms, and/or abnormal laboratory results. If the 
final diagnosis is not known at the time of initial detection, the provisional diagnosis or signs or 
symptoms should be recorded and updated when the final diagnosis is available.


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7.6.6.2.
Definition of a Serious Adverse Event
An SAE is defined as an event that, at any dose, results in the following:

Death

A life-threatening situation (Note: The term “life-threatening” in the definition of “serious” 
refers to an event in which the subject was at risk of death at the time of the event; it does not 
refer to an event that hypothetically might have caused death if it were more severe.)

Inpatient hospitalization or prolongation of existing hospitalization

Persistent or significant disability/incapacity

A congenital anomaly/birth defect (in the child of a subject who was exposed to the study 
treatment)

A medically important event or reaction: Such events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the subject or may 
require intervention to prevent 1 of the other outcomes constituting SAEs. Medical and 
scientific judgment must be exercised to determine whether such an event is reportable under 
expedited reporting rules. Examples of medically important events include intensive 
treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or 
convulsions that do not result in hospitalization; and development of drug dependency or 
drug abuse.
7.6.6.3.
Protocol-Specific Serious Adverse Event Reporting Exemptions
An SAE does not include:

Progression of disease

Hospitalization for a routine clinical procedure as stipulated by the protocol

Pre-planned treatments or surgical procedures requiring hospitalization (the conditions 
should be documented as appropriate in the eCRF)

Hospitalization due to signs and symptoms of disease progression

Hospitalization for nonmedical reasons (i.e., social admissions, hospitalizations for social, 
convenience, or respite care)


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Death is an outcome of an SAE and not, in itself, an SAE. When death is an outcome, the 
event(s) resulting in death should be reported (e.g., “pulmonary embolism” with a fatal 
outcome). The appropriate diagnosis (i.e., cause of death) should be recorded and assigned 
severity Grade 5. Fatal AEs meeting these criteria are SAEs and should be reported to the 
Sponsor or the Sponsor’s designee in accordance with the timelines specified in Section 7.6.6.4.
Deaths related to progression of underlying disease during the study will not be reported as an 
SAE if, in the Investigator’s judgment, the event is unequivocally due to the expected course of 
progression of the underlying disease and not due to another cause.
7.6.6.4.
Follow-up of Adverse Events
All subjects will be followed for AEs until 30 days post-treatment or until resolution or 
stabilization of all treatment-related AEs to either ≤Grade 2 or baseline, whichever is longer, or 
until the subject is lost to follow-up.
Any SAE that occurs >30 days from the last dose of study treatment and is assessed as possibly 
related to study drug must be reported and should be followed to resolution or, if resolution is 
unlikely, to stabilization.
7.6.6.5.
Recording of Adverse Events
All AEs from the time the subject signs the informed consent and until 30 days after the last dose 
of study drug must be recorded. During the period after informed consent has been obtained and 
before the first dose of study drug has been administered, only SAEs caused by a 
protocol-mandated intervention (e.g., biopsy) should be reported. Any SAE that occurs 30 days 
after the last dose of study drug and is assessed as possibly related to study drug must be 
reported.
It is the responsibility of the Investigator to document all AEs that occur during the study. All 
AEs regardless of seriousness, severity, or relationship to the study drug, that occur during the 
safety reporting period, must be recorded in the AE page of the eCRF. AEs should be elicited by 
asking the subject a non-leading question (e.g., “have you experienced any new or changed 
symptoms since we last asked/since your last visit?”). AEs can also represent abnormal findings 
from physical examinations; laboratory tests; and other study procedures (i.e., ECGs). The 
Investigator must review all laboratory and test data; abnormal findings should be assessed to 
determine if they meet the criteria for AEs (Section 7.6.6.1 and Section 7.6.6.2).
For all AEs, the investigator must pursue and obtain information adequate to assess whether it 
meets the criteria for classification as an SAE (Section 7.6.6.2) and, therefore, requires 
immediate notification to the Sponsor or its designated representative.
To assist in the Sponsor’s assessment of each case, further information may be requested from 
the Investigator to provide clarity and understanding of the event in the context of the clinical 
trial.


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7.6.6.6.
Reporting Requirements
All SAEs and pregnancies must be reported to the Sponsor or the Sponsor’s designee 
immediately, and no later than 24 hours of becoming aware of the event. All SAEs and 
pregnancies should be reported to the Sponsor as per the reporting instructions provided on the 
Completion Guidelines and as stated on the SAE Form, Pregnancy Report Form, and Pregnancy 
Outcome Report Form.
The initial SAE report should be as complete as possible; however, reporting should not be 
delayed in order to obtain more information. All follow-up information should be reported within 
24 hours of the Investigator’s awareness of the information. The Investigator is required to 
provide follow-up information in response to queries from the Sponsor or Sponsor’s designee. 
Hospital discharge summaries should be provided for subjects who are hospitalized and autopsy 
findings, if available, should be provided for subjects who die; however, reporting should not be 
delayed in order to obtain more information. All follow-up information should be reported within 
24 hours of the Investigator’s awareness of the information. The Investigator is required to 
provide follow-up information in response to queries from the Sponsor or Sponsor’s designee.
Pregnancy occurring in a female subject during dosing or within 1 month after the end of 
treatment should be reported to the Sponsor or Sponsor’s designee on the Pregnancy Form within 
24 hours of the Investigator becoming aware of the event. Pregnancy occurring in female 
partners of male subjects while the male partner is receiving study drug and within 1 month after 
the final dose should be reported to the Sponsor or Sponsor’s designee within 24 hours of 
becoming aware of the event.
The Investigator should counsel the subject, and in the case of a male subject, the subject’s 
partner, regarding the risks of continuing with the pregnancy and the possible effects on the 
fetus.
If the female partner of a male subject becomes pregnant, the investigator should obtain 
informed consent of the pregnant partner prior to monitoring the pregnancy, so that information 
regarding the pregnancy outcome can be reported to the Sponsor or Sponsor’s designee.
Information regarding the pregnancy should include estimated date of conception, duration of 
study drug exposure (or number of days/months after treatment discontinuation) as of the 
estimated conception date, expected delivery date, date of last menstrual period, all concomitant 
medications (including recreational drug use such as alcohol, tobacco, and illicit drugs), and 
other maternal medical conditions.
The Investigator should make every effort to follow the subject (or female partner of a male 
subject) through the resolution of the pregnancy (i.e., delivery or pregnancy termination). If the 
pregnancy results in abortion (spontaneous or induced), premature birth, or if the infant is born 
with a congenital anomaly, these events are considered SAEs and should be reported. The 
outcome of all pregnancies must be reported to the Sponsor or Sponsor’s designee, even for 
normal births. The condition of the infant at birth should be reported, including any anomalies, 
and the infant should be followed until 3 months of age and any illnesses should be reported.


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All information regarding the pregnancy in a female subject or female partner of a male subject 
and the infant should be reported on the Pregnancy Form.
The Investigator must notify his/her local Institutional Review Board (IRB)/Independent Ethics 
Committee (IEC) about certain AEs, including suspected unexpected serious adverse reactions 
(SUSARs) in accordance with the IRB/EC’s policies and procedures and GCP/International 
Council for Harmonisation (ICH) guidelines.
7.6.6.7.
Assessment of Adverse Event Severity
The severity of AEs will be graded using NCI-CTCAE Version 5.0. For each SAE, the highest 
severity grade should be reported. If a CTCAE criterion does not exist, the Investigator should 
assess the severity according to the criteria in Table 7.
Table 7.
Grading for Adverse Events Not Listed in NCI-CTCAE
CTCAE 
Grade
Severity
Definition
Grade 1
Mild
Asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated
Grade 2
Moderate
Minimal, local or noninvasive intervention indicated; limiting 
age-appropriate instrumental activities of daily life1
Grade 3
Severe
Severe or medically significant, but not immediately life-threatening; 
hospitalization or prolongation of existing hospitalization indicated; 
disabling; limiting self-care activities of daily life2,3
Grade 4
Life-threatening
Life-threatening consequences; urgent intervention indicated3
Grade 5
Death
Results in death
1
Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.
2
Self- care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not 
bedridden.
3
These events should be assessed to determine if they meet the definition of SAEs.
7.6.6.8.
Assessment of Adverse Event Causality
The Investigator’s causality assessment is required for all AEs, including both non-serious and 
serious AEs. The causality assessment is the determination of whether there exists a reasonable 
possibility that the study treatment caused or contributed to an AE. In order to determine 
causality, the Investigator should consider the temporal relationship of event onset to the start of 
study drug; the course of the event and, in particular, whether the event resolves or improves 
with dose reduction or study drug discontinuation; the known toxicities of the study drug; events 
expected to occur in subjects with the disease under study; and concomitant medications and 
comorbidities which may have a known association with the event. Causality is to be assessed as 
follows:


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
Related: Plausible time relationship to study treatment administration; plausible time 
relationship of improvement or resolution with study drug dose reduction or discontinuation; 
event cannot be explained by the underlying disease, comorbidities, or concomitant 
medications

Possibly related: a reasonable time sequence to administration of study drug, but which could 
also be explained the underlying disease, comorbidities, or concomitant medications

Unlikely related: a temporal relationship to drug administration which makes a causal 
relationship improbable and the underlying disease, comorbidities, or concomitant 
medications provide a plausible explanation

Not related: a causal relationship to the study drug can be easily ruled out
7.6.6.9.
Adverse Events Based on Abnormal Test Findings
An abnormal laboratory test finding that meets any 1 of the following criteria should be 
considered an AE:

Test result is associated with accompanying symptoms

Test result requires additional diagnostic testing or medical/surgical intervention

Test result leads to a change in study treatment dosing (e.g., dose modification, interruption, 
or permanent discontinuation) or concomitant drug treatment (e.g., addition, interruption, or 
discontinuation) or any other change in a concomitant medication or therapy

Test result leads to any of the outcomes included in the definition of an SAE (see 
Section 7.6.6.2; Note: this would be reported as an SAE)

Test result is considered an AE by the Investigator
Laboratory results that fall outside the reference range and do not meet 1 of the criteria above 
should not be reported as AEs. Repeating an abnormal test, in the absence of the above 
conditions, does not constitute an AE. Any abnormal test result that is determined to be an error 
does not require reporting as an AE.
Any abnormal test finding that meets the criteria for an SAE (Section 7.6.6.2) should be reported 
as such.
7.6.6.10.
Study Drug Action Taken
The Investigator will determine the study drug action taken with regard to the AE. The action 
taken should be classified according to the categories shown in Table 8.


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Table 8.
Classification for Study Drug Action Taken with Regard to an 
Adverse Event
Classification
Definition
Dose Not Changed
Study drug dose or frequency not changed in response to an AE
Dose Reduced
Study drug dose reduced in response to an AE 
Drug Interrupted
Study drug administration interrupted in response to an AE
Drug Withdrawn
Study drug administration permanently discontinued in response to an AE
Not Applicable
Action taken regarding study drug administration does not apply.
“Not applicable” should be used in circumstances such as when the investigational 
treatment had ended before the AE began and no opportunity to decide whether to 
continue, interrupt, or withdraw treatment is possible.
AE = adverse event
7.6.6.11.
Adverse Event Outcome and Treatment Given
An AE should be followed until the Investigator has determined and provided the final outcome. 
The outcome should be classified according to the categories shown in Table 9.
Table 9.
Classifications for Outcome of an Adverse Event
Classification
Definition
Recovered/Resolved
Resolution of an AE with no residual signs or symptoms
Recovered/Resolved with 
Sequelae
Resolution of an AE with residual signs or symptoms
Recovering/Resolving 
(Ongoing)
Improvement of an AE but not yet resolved
Not Recovered/Not Resolved 
(Ongoing)
No improvement of an AE, such that it remains ongoing
Fatal
Outcome of an AE is death. “Fatal” should be used when death is at least possibly 
related to the AE
Unknown
Outcome of an AE is not known (e.g., a subject lost to follow-up)
AE = adverse event
The Investigator will ensure adequate medical care is provided to subjects for AEs. In addition, 
the Investigator will describe whether any treatment was given for the AE. “Yes” is used if any 
treatment was given in response to an AE and may include treatments such as other medications, 
hospitalization, radiation therapy, surgery, or physical therapy. “No” indicates the absence of any 
kind of treatment for an AE.
7.6.6.12.
Investigator Notification to Local Institutional Review Boards
The Investigator must notify his/her local IRB/IEC about certain AEs, including SUSARs in 
accordance with the IRB/IEC’s policies and procedures and GCP/ICH guidelines.


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7.6.6.13.
Sponsor Responsibilities
The Sponsor or designee will be responsible for reporting all AEs, SAEs, and SUSARs to the 
appropriate regulatory authorities, Investigators, and Central IRBs in accordance with all 
applicable regulations and guidance documents.
Events otherwise meeting the definition of SUSARs but related to TPC do not require reporting 
to regulatory authorities, Investigators, and Central IRBs, but will be reported by the Sponsor to 
the respective product manufacturers.
7.7.
Immunogenicity
Serum samples for ADA testing will be collected from all subjects in the sacituzumab govitecan 
arm according to the Schedule of Assessments (see Appendix 4). ADA will be evaluated by the 
Sponsor’s designee using a validated 3-tier (screen, confirm, titer) assay. Instructions for 
shipping these serum samples are provided in Appendix 3.
7.8.
Pharmacokinetic Evaluations
Serum samples will be collected from all subjects in the sacituzumab govitecan arm for 
measurement of individual and mean concentration-time concentrations of total SN-38, free 
SN-38, total antibody (hRS7 IgG) and SN-38G. Samples are to be shipped to the Sponsor’s 
designee who will perform these assays. Instructions for shipping these samples are provided in 
Appendix 3.
7.9.
UGT1A1 Genotype
UGT1A1 genotype will be evaluated by the Sponsor’s designee for all subjects in the 
sacituzumab govitecan arm from a blood sample collected at Baseline.
7.10.
Blood Biomarker Evaluations
Blood samples for biomarker analysis will be collected according to the Schedule of 
Assessments (see Appendix 4) and will be retained for future analysis. Details of blood 
collection are provided in the Laboratory Manual. This research will be focused on identifying 
future marker(s) that can better predict response as well as to identify mechanisms of resistance 
that can provide a more accurate prognosis in subjects treated with sacituzumab govitecan.
Participation in the future use of specimens is optional and is not required in order to be eligible 
for the study. Subjects can withdraw consent for future use at any time by contacting their site.
Samples may be stored for testing for up to 15 years after the completion of the study or until the 
sample is gone. When the 15-year period ends, the samples will be destroyed. Samples will be 
retained for longer than 15 years if a Health Authority (or medicinal product approval agency) 
has active questions about the study, in which case, samples will be stored until the Health 
Authority’s (or medicinal product approval agency’s) questions have been addressed.


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Specimens will be de-identified and coded only with a study identification number unique to the 
subject and will be stored in a limited access, secure facility. Only the Investigator will retain and 
have access to the code list that matches the study code to the subjects’ identifying information.
Access to samples and/or results from the research will be limited to the Sponsor, their research 
partners, or laboratories contracted to perform work for the Sponsor.


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8.
SCHEDULE AND SEQUENCE OF PROCEDURES
Study-specific assessments are outlined in the Schedule of Assessments in Appendix 4. Unless 
otherwise specified, collection windows for study time points are within ±2 days for the 
treatment schedule and ±7 days for response assessments. Collection windows for PK samples 
are ±15 minutes on infusion days.
8.1.
Pre-Randomization Phase
The Pre-randomization Phase will last no longer than 28 days and consists of the following 
two periods: Screening Period (Day -28 to Day -3) and Baseline Period (Day -3 to Day 1 prior to 
dosing). See Appendix 4 for the schedule of Screening and Baseline assessments.
8.2.
Randomization Phase
The Randomization Phase will begin at the time of randomization of the first subject and will 
end on the data cut-off date for the final analysis of OS. The Randomization Phase consists of the 
following two periods: a Treatment Period and a Follow-up Period (see Section 8.2.1 and 
Section 8.2.2, respectively).
8.2.1.
Treatment Period
The Treatment Period begins at the time of randomization and ends with the completion of the 
EOT visit, which will occur at least 30 days after the last dose of sacituzumab govitecan or TPC 
and before the start of other treatments or in the event of premature study termination.
Subjects will continue to receive study treatment until RECIST 1.1 disease progression by LIR, 
development of unacceptable toxicity, subject request, withdrawal of consent, Investigator 
decision, pregnancy, or study termination by the Sponsor.
All subjects will be permitted to continue treatment in the Treatment Period beyond initial 
RECIST 1.1 defined progression as long as the Investigator believes that the subject is still 
receiving clinical benefit and is clinically stable and tolerating study drug treatment. The 
assessment of clinical benefit should consider the potential efficacy benefit versus the safety risk 
of continuation of treatment. These subjects must continue tumor assessments at the same 
interval in the Treatment Period until further progression and/or loss of clinical benefit, as judged 
by the Investigator. At that time subjects discontinue study treatment, they will have their EOT 
visit and move to the Follow-Up Period.
Clinical stability is defined by the following criteria:
1) Absence of symptoms and signs indicating clinically significant progression of disease, 
including worsening of laboratory values, and
2) No decline in ECOG performance status, and


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3) Absence of rapid progression of disease, and
4) Absence of progressive tumor at critical anatomical sites (e.g., cord compression) requiring 
urgent medical and/or surgical intervention
See Appendix 4 for the schedule of assessments during the Treatment Period.
8.2.2.
Follow-up Period
The Follow-up Period begins the day after the EOT visit and continues as long as the subject is 
alive or until the data cut-off date of the final analysis of OS, unless the subject withdraws 
consent from the study or the Sponsor terminates the study. If a subject discontinues study 
treatment and does not consent to continued follow-up, the Investigator must not access 
confidential records that require the subject’s consent. However, an Investigator may consult 
public records to establish survival status.
Subjects who enter the Follow-Up Period due to disease progression may be treated by the 
Investigator according to the local standard of care. Subjects will be followed every 12 weeks 
±1 week for survival status and subsequent anticancer treatment received.
Subjects who enter the Follow-up Period prior to disease progression will continue to undergo 
tumor assessments every 12 weeks ±1 week until disease progression is documented or another 
anticancer therapy is initiated. At that time, these subjects will then be contacted for survival 
status and subsequent anticancer treatment received, unless the subject withdraws consent for the 
study.
See Appendix 4 for the schedule of assessments during the Follow-up Period.
8.3.
End of Study
End of study is defined as the point in time when the number of death events required for the 
final OS analyses have been reached or if the Sponsor terminates the study, whichever comes 
first. At the end of study, in the event that the Investigator believes a subject is continuing to 
receive clinical benefit, the Sponsor will discuss options with the Investigator in order to ensure 
the potential for continuing supply of sacituzumab govitecan.
Subjects who are deriving benefit from sacituzumab govitecan after evaluating the primary and 
secondary efficacy outcome measures and safety data gathered in the study may continue to 
receive treatment in a rollover study, if such a study is available to the subject.


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9.
STATISTICAL CONSIDERATIONS
9.1.
Determination of Sample Size
The sample size is estimated based on the primary end point of PFS, but also taking into 
consideration OS as the main secondary end point. An overall sample size of approximately 
520 subjects were randomized in a 1:1 ratio to either sacituzumab govitecan (Investigational 
Arm A) or TPC (Control Arm B).
For PFS, assuming a hazard ratio of 0.70 (medians of 5.3 months in Arm A and 3.7 months in 
Arm B), a total of 350 PFS events will be used to detect a statistically significant difference at a 
2-sided alpha of 0.05 with 92% power. With an estimated average accrual rate of 22 subjects per 
month, a total of 520 subjects will provide 350 PFS events approximately 27 months after the 
first subject is randomized, after accounting for events being censored because of subjects 
missing tumor assessments or starting subsequent anti-cancer therapies (see primary end point 
PFS definition in Section 9.5.1). The recruitment rate is assumed to be non-uniform so that half 
of the subjects are recruited 55% of the way through the recruitment period of approximately 
24 months, reflecting the change in sample size and actual recruitment rate that was affected by 
the global COVID-19 pandemic.
At PFS final analysis, OS will be summarized descriptively only. To be conservative, the 
nominal 2-sided alpha of 0.00001 will be spent even without formal hypothesis testing. For OS, 
assuming a hazard ratio of 0.73 (median of 16.5 months in Arm A and 12 months in Arm B), a 
total of 438 OS events are needed to detect a statistically significant difference with 86.7% 
power at a 2-sided alpha of 0.04999 based on a recruitment period of approximately 24 months 
and 52 months of survival follow-up from the first subject randomized.
The Sponsor will closely monitor the number of subjects randomized and discontinued, 
including subjects who refuse study treatment assigned. As the primary analysis is triggered by a 
targeted number of PFS events, subjects who prematurely discontinue from the study or whose 
events are censored do not count toward the targeted number. To compensate for such cases, an 
additional number of subjects is necessary to be enrolled to ensure the targeted number of events 
is reached within a reasonable timeframe. If required, the additional number of subjects will be 
determined by the Sponsor on the basis of the number and pattern of accumulated and censored 
events at the appropriate times as the study progresses.
9.2.
Interim Analysis
An independent DSMC will be formed for the study. The function and membership of the 
DSMC will be described in a DSMC charter. Safety monitoring will be conducted by the DSMC 
according to the schedule defined in the DSMC charter.


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A descriptive, non-comparative analysis of OS will be performed when the final primary analysis 
of PFS is performed. The purpose of this analysis is to examine the OS effect of sacituzumab 
govitecan, at the time when the primary end point PFS of this study is determined. It is estimated 
that 205 OS events will occur at this time of analysis; an administrative alpha of 0.00001 will be 
spent on this non-comparative analysis of OS.
The study is planned to have 2 superiority interim efficacy analyses of the main secondary end 
point, OS, performed when approximately a total of 272 (62% information fraction) and 
350 (80% information fraction) death events have occurred, respectively. The method used to 
account for the multiplicity introduced by efficacy interim analyses is described in Section 9.3.
There is no planned interim analysis of PFS in this study.
9.3.
Multiplicity
The overall type I error rate for this study is strictly controlled at a 2-sided alpha of 0.05. The 
primary end point analysis of PFS assessed by BICR will serve as the gatekeeper for the 
secondary end point analyses and be tested at the 2-sided alpha of 0.05. At PFS final analysis, 
OS will be summarized descriptively only. To be conservative, the nominal 2-sided alpha of 
0.00001 will be spent even without formal hypothesis testing. If the primary PFS analysis is 
positive, analysis of the main secondary end point of OS will be formally tested sequentially at 
the 2-sided alpha of 0.04999, ORR (assessed by BICR) and analysis for QOL will be formally 
tested sequentially at the 2-sided alpha of 0.05, respectively, when the above hypotheses in the 
hierarchy are also statistically significant. For analysis of QOL, TTD of global health 
status/QOL, pain, and fatigue domains as measured by EORTC QLQ-C30 will be tested using 
graphical approach of Maurer and Bretz to control multiplicity {Maurer 2013}. According to this 
approach, the hypotheses may be tested more than once, and when a particular null hypothesis is 
rejected, the alpha allocated to that hypothesis can be reallocated to other hypothesis tests. The 
arrows in Figure 4 show how the type I error allocated to a null hypothesis that is successfully 
rejected will be redistributed for the testing of the other hypotheses. Please note that the arrows 
do not necessarily indicate the testing order. A Bonferroni approach is used to control the type I 
error rate at 0.05 (2-sided) alpha for the 3 TTD hypothesis tests.
The Lan-DeMets alpha spending function that approximates a Pocock approach will be used to 
account for multiplicity introduced by including OS interim analyses for superiority. The first OS 
efficacy interim analysis will be tested at the 2-sided significance level of 0.0363 if 62% of the 
death events (272/438) is available at the time of the analysis. If the first OS interim analysis is 
not positive, the second OS efficacy interim analysis will be tested at the 2-sided significance 
level of 0.0206 if 80% of death events (350/438) is available at the time of the analysis. If neither 
of the interim analyses are positive, final analysis will be tested at the 2-sided significance level 
of 0.0195. Note that alpha levels for the OS interim and final analyses are based on the actual 
observed events and will be adjusted accordingly.


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Figure 4.
Hierarchical Testing Procedures
BICR = blinded independent central review; EORTC QLQ-C30 = European Organization for Treatment of Cancer Quality of 
Life questionnaire version 3.0; FA = final analysis; IA = interim analysis; ITT = Intent-to-Treat; OS = overall survival; PFS = 
progression-free survival
9.4.
Analysis Sets
The following analysis sets will be used as defined and used for analysis:

Screened Set is the group of all subjects who have signed an informed consent and 
participated in screening procedures at the investigative site to assess eligibility. This 
analysis population is used for selected tables and listings pertaining to subjects’ disposition 
and eligibility criteria.
Yes 
PFS assessed by BICR in ITT 
2-side a= 0.05 
Descriptive OS in ITT 
2-sided a= 0.00001 
Yes 
OS in ITT 2-sided a= 0.04999 
---. 
---. 
No 
No 
Yes 
ORR assessed by BICR in ITT 
2-sided a= 0.05 
l 
Yes 
Time to deterioration of 
global health status/Qol 
as measured by EORTC 
QLQ-C30 
0.5 
0.5 
2-sided 1/3 a 
No 
No 
No 
Time to deterioration 
of fatigue as 
measured by EORTC 
QLQ-C30 
2-sided 1/3 a 
~05 
05 
01/ 
r-T-im_e_t_o_d_e-te-r-io-ra-t-io_n_ 
1/.5 
of pain as measured 
by EORTC QLQ-C30 
2-sided 1/3 a 
Stop 
Stop 
Stop 


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
Full Analysis Set (Intent-to-Treat Analysis [ITT] Population) is the group of all 
randomized subjects. This is the primary analysis population for all efficacy analyses which 
will be based on the ITT principle, with subjects analyzed according to the randomized 
treatment assignment.

Safety Analysis Set is the group of subjects who received at least 1 dose of study drug. This 
is the analysis population for all safety analyses which will be based on the actual treatment 
received.

HRQoL-Evaluable Set is the all ITT population who had an evaluable assessment of the 
HRQoL at baseline and at least one evaluable assessment at post-baseline visits. An 
evaluable assessment at a given visit will be defined as at least one of the 15 domains/scales 
were non-missing at that scheduled assessment visit.

PK Set is defined as Safety population subjects who have completed at least one cycle of 
sacituzumab govitecan treatment and have at least one non-missing PK concentration of total 
SN-38, free SN-38, total antibody (hRS7 IgG) and/or SN-38G
9.5.
Efficacy Analyses
Primary analysis of PFS will be based on BICR assessments. PFS, ORR, CBR and DOR 
analyses will be produced for both BICR and LIR.
9.5.1.
Primary Efficacy Analyses
PFS is defined as the time from the date of randomization to the date of the first documentation 
of disease progression or death (whichever occurs first) according to BICR using RECIST 1.1. 
Any subject who progresses or dies after more than one missed scheduled visit will be censored 
at the last date of radiographic assessment prior to the missed visit. Any subject who receives 
alternative anticancer treatment before documented PD will be censored at the last date of 
radiographic assessment prior to receiving alternative anticancer treatment. Otherwise, subjects 
who do not have progression and are alive will be censored at the last date of radiographic 
assessment without documented PD. Subjects who did not have any on study tumor assessments 
and did not die will be censored on their date of randomization.
The primary analysis of PFS will be carried out after approximately 350 subjects experience 
disease progression or death events according to the primary definition of PFS as assessed by 
BICR.
PFS will be described using Kaplan-Meier (K-M) estimates. The primary analysis of PFS for the 
comparison between treatment arms will be performed using a stratified log rank test with the 
stratification factors used in the randomization. Median PFS and its 95% CI as determined by the 
Brookmeyer and Crowley method with log-log transformation will be presented and the K-M 
estimates of PFS will be plotted over time. Hazard ratio of PFS and its 95% CI will be estimated 
using Cox proportional-hazards model stratified by the same stratification factors used in the 
randomization.


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9.5.2.
Secondary Efficacy Analyses
Secondary efficacy analyses include the following:

OS is defined as the time from the date of randomization to the date of death from any cause. 
Subjects who are lost to follow-up and those who are alive at the date of data cut-off will be 
censored at the date the subject was last known alive or date of data cut-off, whichever 
occurs first.

ORR is defined as the proportion of subjects who have a best overall response of either CR 
or PR that is confirmed ≥ 4 weeks later according to BICR using RECIST 1.1.

TTD of global health status/QOL, pain, and fatigue domains of the EORTC QLQ-C30 is 
defined as the time between randomization and the time a subject experienced a deterioration 
(i.e., ≥ 10 points worsening from baseline in a given domain).

DOR is defined as the time from the date a response was first documented until the date of 
the first documentation of disease progression or date of death (whichever occurs first). 
Subjects who neither progress nor die will be censored on the date of their last tumor 
assessment. DOR will be evaluated for responders (CR or PR) only.

CBR is the proportion of subjects who have best overall response of CR or PR or durable SD 
(duration of SD ≥ 6 months after randomization).
At the time of primary analysis of PFS is performed, OS will be summarized descriptively. No 
other formal treatment comparison for OS will be performed at this time.
The analysis of OS will be described using K-M estimates. The primary analysis of OS for 
comparison between treatment arms will be performed using a stratified log rank test with the 
same stratification factors used in the randomization. Median OS and the associated 95% CI as 
determined by the Brookmeyer and Crowley method with log-log transformation will be 
presented. Hazard ratio and the associated 95% CI will be estimated using a Cox 
proportional-hazards model stratified by the same stratification factors used in the 
randomization.
ORR will be analyzed and compared between the treatment arms using the Cochran 
Mantel-Haenszel (CMH) test stratified by the stratification factors used in the randomization. 
The 2-sided 95% CIs will be calculated using the Clopper-Pearson exact method.
CBR will be calculated with exact 95% CIs using the method of Clopper and Pearson. CBR will 
be compared between treatment arms using a CMH test stratified by the stratification factors 
used in the randomization. The differences and odds ratios of these rates between treatment arms 
and 95% CIs will be calculated respectively.
The K-M estimates of median DOR and its 95% CI will be calculated for responders (CR or PR) 
in each treatment arm.


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Time to deterioration of global health status/QOL, pain, and fatigue domains as measured by 
EORTC QLQ-C30 will be analyzed similarly as the primary analysis of PFS.
A separate prespecified HRQOL analysis following Food and Drug Administration (FDA) and 
European Medicines Agency PRO Guidelines will be performed.


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9.5.3.
Sensitivity Analyses
The following sensitivity analyses will be conducted for the primary end point of PFS in order to 
evaluate the robustness of the results:

Sensitivity Analysis 1 of PFS will use the same censoring rule of the primary PFS definition 
except that any subject who progresses or dies after more than one missed scheduled tumor 
assessment will not be censored at the last date of radiographic tumor assessment prior to the 
missed assessment.

Sensitivity Analysis 2 of PFS will use the same censoring rule of the primary PFS definition 
except that it considers discontinuation of treatment or initiation of alternative anticancer 
treatment, whichever occurs later, to be a PD event for subjects without documented 
progression or death.

Sensitivity Analysis 3 of PFS will use the same primary PFS definition, but for all treated 
subjects who received at least one dose of study drug.
All three sensitivity analyses will be conducted on both BICR and LIR assessments.
9.5.4.
Subgroup Analyses
To evaluate whether the treatment effect is consistent across various subgroup populations, the 
estimate of the between-group treatment effect with a 95% CI for the primary and secondary end 
points will be estimated and plotted graphically for the following subgroups, including but not 
limited to:
1) Stratification factor of number of prior chemotherapy regimens for treatment of metastatic 
disease (two vs. three/four lines)
2) Stratification factor of visceral metastasis (Y/N)
3) Stratification factor of endocrine therapy in the metastatic setting for ≥ 6 months (Y/N)
4) Age group (< 65 years old or ≥ 65 years old)
5) Race (white, non-white)
6) Baseline ECOG status (0 vs 1)
7) Geographic region (North America, Europe, and elsewhere)
8) Prior CDK treatment duration (≤ 12 months or > 12 months)
9) Investigators’ choice of chemotherapy (eribulin, capecitabine, gemcitabine, vinorelbine)


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10) Early progressors (YIN) ( defined as progressing to metastatic disease within 1 year of 
neo/adjuvant therapy) 
11) Baseline documented Target or Non-Target liver lesions per RECIST 1.1 (YIN) 
12) Chemotherapy in neo/adjuvant setting (YIN) 
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9.6.
Safety Analyses
Safety analyses will be based on the Safety Analysis Set. All safety analyses will be summarized 
by treatment arm. Treatment-emergent AEs and SAEs, laboratory test results, vital signs, and 
ECG results will be summarized. Safety data will be summarized using descriptive statistics. 
Categorical variables will be summarized by number and percentage. Continuous variables will 
be summarized using number of subjects, mean, standard deviation, median, upper and lower 
quartiles, and range (minimum and maximum), unless otherwise specified.


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10.
TREATMENT COMPLIANCE
Sacituzumab govitecan will be administered at scheduled study centers under the supervision of 
the Investigator or sub-Investigator(s). The pharmacist will maintain records of study drug 
receipt, preparation, and dispensing, including the applicable lot numbers, subject’s height, 
weight and total drug administered in milligrams. Any discrepancy between the calculated dose 
and dose administered and the reason for the discrepancy must be recorded in the source 
documents and on appropriate CRF.


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11.
QUALITY CONTROL AND QUALITY ASSURANCE
The Sponsor has ethical, legal and scientific obligations to follow this study carefully in a 
detailed and orderly manner in accordance with established research principles and applicable 
regulations. Monitoring visits to the study site will be conducted periodically during the study to 
ensure that GCP and all aspects of the protocol are followed. The trial site may also be subject to 
review by the IRB/IEC, to quality assurance audits performed by the Sponsor’s designee and/or 
to inspection by appropriate regulatory authorities. Investigator(s) and their relevant personnel 
must agree to be available and participate with visits conducted at a reasonable time in a 
reasonable manner, and the Investigator/Institution must guarantee direct access to source 
documents by the Sponsor and its designee, and appropriate regulatory authorities.
Regulatory authorities worldwide may also audit the Investigator during or after the study. The 
Investigator should contact the Sponsor’s designated contact immediately if this occurs and must 
fully cooperate with regulatory authority audits conducted at a reasonable time in a reasonable 
manner.


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12.
DATA HANDLING AND RECORD KEEPING
12.1.
Electronic Case Report Forms
An eCRF is required and must be completed for each enrolled subject. The completed original 
eCRFs are the sole property of the Sponsor and should not be made available in any form to third 
parties, except for authorized representatives of appropriate regulatory authorities, without 
written permission from the Sponsor.
It is the Investigator's responsibility to ensure completion and to review and approve all eCRFs. 
eCRFs must be signed by the Investigator or by an authorized staff member. These signatures 
serve to attest that the information contained on the eCRFs is true. At all times, the Investigator 
has final personal responsibility for the accuracy and authenticity of all clinical and laboratory 
data entered on the eCRFs. Subject source documents are the physician's subject records 
maintained at the study site. In most cases, the source documents will be the hospital's or the 
physician's chart. In cases where the source documents are the hospital or the physician's chart, 
the information collected on the eCRFs must match those charts.
12.2.
Record Retention
Records and documents pertaining to the conduct of this study, including eCRFs, source 
documents, consent forms, laboratory test results, and medication inventory records must be 
retained by the Investigator for at least 15 years. No study records shall be destroyed without 
prior authorization from the Sponsor. For studies conducted outside the US under a US 
Investigational New Drug (IND), the Investigator must also comply with US FDA IND 
regulations, ICH guidelines, and with the regulations of the relevant national and local health 
authorities.
12.3.
Good Clinical Practice
The study will be conducted in accordance with the ICH for GCP and the appropriate local and 
national regulatory requirement(s). The Investigator will be thoroughly familiar with the 
appropriate use of the study medications as described in the protocol and Investigator’s 
Brochure. Essential clinical documents will be maintained to demonstrate the validity of the 
study and the integrity of the data collected. Master files for this study should be established at 
the beginning of the study, maintained for the duration of the study, and retained according to the 
appropriate regulations.


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12.4.
Ethical Considerations
This study is planned to be conducted in North America, Europe, and potentially elsewhere. 
European regulatory agencies require that the study will be conducted in accordance with ethical 
principles founded in the Declaration of Helsinki. The trial will be performed in accordance with 
ICH GCP guidelines, the Declaration of Helsinki, 18th World Medical Assembly, Helsinki, 
Finland, 1964 and later revisions (as mandated for European trials), and applicable local 
regulatory requirements and laws. In the US, ethical protection is provided by compliance with 
GCPs as described in ICH and 21 CRF 50 (Protection of Human Subjects).
The IRB and the IEC will review all appropriate study documentation in order to safeguard the 
rights, safety and well-being of the subjects. The study will only be conducted at sites where 
IRB/IEC approval has been obtained. The Investigator is responsible for providing their IRB/IEC 
with any required study documents, progress reports and safety updates and is responsible for 
notifying the IRB/IEC promptly of all SAEs occurring at the site.
All correspondence with the IRB/IEC should be retained in the Investigator File. Copies of 
IRB/IEC approvals should be forwarded to the Sponsor or the designee.
The only circumstance in which an amendment may be initiated prior to IRB/IEC approval is 
where the change is necessary to eliminate apparent immediate hazards to the subjects. In that 
event, the Investigator must notify the IRB/IEC and the Sponsor or its designee in writing within 
5 working days after the implementation.
12.5.
Subject Information and Consent
It is the responsibility of the Investigator to give each subject (or the subject’s acceptable 
representative) full and adequate verbal and written information regarding the objective and 
procedures of the trial including the possible risks and benefits involved. Written subject 
information, approved by the IRB/IEC, must be given to each subject before any trial-related 
procedure is undertaken. During the consent process, the subject must be informed about their 
right to withdraw from the trial at any time. The subject must also be given ample time to read 
the written ICF and have all study-related questions answered to the satisfaction of the subject 
(or the subject’s legally acceptable representative). It is the responsibility of the Investigator to 
obtain a signature from each subject, the subject’s legally acceptable representative (if 
applicable), and from the persons conducting the informed consent discussion prior to 
undertaking any trial-related procedure. The subject (or the subject’s legally acceptable 
representative) must be given a copy of the signed and dated ICF. The Investigator is also 
responsible for providing the subject (or the subject’s legally acceptable representative) with any 
clinical trial updates that may affect the subject’s willingness to continue participation in the 
study. The informed consent process must be documented in the subject’s medical or source 
chart.
The written subject information must not be changed without prior approval of the IRB/IEC.


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Per ICH E6 4.3.3, it is recommended that the Investigator notify the subject’s primary care 
physician of the subject’s participation in the trial if the subject agrees to the Investigator 
informing the primary care physician.
In a case in which a subject is allowed to continue treatment after progression, the subject will be 
required to sign another ICF to ensure awareness that the subject will be foregoing other 
therapies, including other clinical trial which may be available.
12.6.
Protocol Compliance
The Investigator will conduct the study in compliance with the protocol provided by the Sponsor 
or its designee and given approval by the IRB/IEC and the appropriate regulatory authorities. 
Changes to the protocol will require written IRB/IEC approval prior to implementation, except 
when the modification is needed to eliminate an immediate hazard(s) to the subject. The 
IRB/IEC may provide, if applicable, expedited review and approval for minor change(s) in 
ongoing studies that have the approval of the IRB/IEC. The Sponsor’s designee will submit all 
protocol modifications to the regulatory authorities in accordance with the governing regulations.
When immediate deviation from the protocol is required to eliminate an immediate hazard(s) to 
subjects, the Investigator will contact the Sponsor’s designee, if circumstances permit, to discuss 
the planned course of action. Any departures from the protocol must be fully documented in the 
subject’s eCRF and source documentation.
12.7.
Site Monitoring and On-Site Audits
Monitoring and auditing procedures developed by the Sponsor or its designee will be followed, 
in order to comply with ICH/GCP; FDA and all applicable guidelines. Review of subject’s 
eCRFs, EMR or paper source documentation for completeness, and accuracy will be required as 
well as a review of all applicable regulatory documents will be performed. All available source 
documents should be obtained by the Investigator and provided to the Sponsor’s designee at each 
monitoring visit.
The site monitor will ensure that the investigation is conducted according to protocol design and 
regulatory requirements by frequent communications.
Off-site monitoring visits and remote source data verification are allowed (if permitted by local 
regulation) when restrictions due to the COVID-19 pandemic prevent on site visits (e.g., 
monitors may not be able to access the sites in a timely manner). (Appendix 10). Should this 
occur, it should be documented and the reasons be available for review by the Sponsor and 
during inspections by any Regulatory Authorities. Remote monitoring should be focused on 
review of critical study site documentation and source data and the monitoring activities, 
including remote review of source documents, should be documented in the same level of detail 
as on-site monitoring activities. Any resulting actions to address issues identified from the 
remote source document review should be consistent with procedures and processes described in 
the study monitoring plan.


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Regulatory authorities, the IRB/IEC, and/or the Sponsor’s clinical quality assurance group or 
designee may request access to all source documents, subject’s eCRFs, and other study 
documentation for on-site audit or inspection. Direct access to these documents must be 
guaranteed by the Investigator, who must cooperate and provide support at all times for these 
activities.
12.8.
Subject Data Protection
Privacy Act Compliance. Information collected in this clinical trial is subject to the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA) as described in 45 Code of 
Federal Regulations (CFR) 160, 45 and 164. The study Investigator is responsible for informing 
subjects of their rights under HIPAA and obtaining any necessary HIPAA authorizations. Any 
clinical study information referred to in this section is understood to be compliant with the 
provisions of the Privacy Act.
Handling of all personal data will be in compliance with the EU General Data Protection 
Regulation.
The information obtained during the conduct of this clinical study is confidential, and disclosure 
to third parties other than those noted below is prohibited. Information obtained during the 
conduct of this study will be used by the Sponsor or designee in connection with the 
development of the study drug. The study Investigator is obliged to provide the Sponsor or 
designee with complete test results and all data developed in this study. This information may be 
disclosed to other physicians participating in the study, to the FDA, or to national and local 
health authorities. To ensure compliance with all current Federal Regulations and the ICH/GCP 
guidelines, data generated by this study must be available for inspection upon request by 
representatives of the FDA, national and local health authorities, the Sponsor or its designee and 
the IRB/IEC for each study site.
12.9.
Financial Disclosure
In accordance with 21 CFR Part 54, FDA requires that certain financial interests and 
arrangements between sponsors of clinical investigations be disclosed in marketing applications. 
Since the results of this study may eventually be used in a marketing application, compliance 
with this Federal statute is essential. In order to comply with the provisions of this regulation, the 
Sponsor requests that every Investigator and sub-Investigator mentioned on FDA Form 1572 fill 
out a financial disclosure form. Under the provisions of 21 CFR Part 54, the term clinical 
Investigator includes the spouse and each dependent child of the Investigator.
The provisions of 21 CFR Part 54 specify disclosure of significant equity interests in the Sponsor 
that exceed $50,000, or significant payments of other sorts made by the Sponsor to the 
Investigator that have a monetary value of more than $25,000, exclusive of the costs of 
conducting the clinical study or other clinical studies (e.g., grants to fund ongoing research, 
compensation in the form of equipment or retainers for ongoing consultation), during the time 
the clinical Investigator is carrying out the study or for 1 year following the completion of the 
study. If a change in financial interest occurs throughout the study, the Investigator is obligated 
to notify the Sponsor.


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To assist the Sponsor or its designee in providing the FDA with the required information, please 
complete the financial disclosure form and return a signed copy. All information provided in the 
financial disclosure form will be regarded as strictly confidential and will only be disclosed to 
the FDA.
12.10.
Sponsor Discontinuation Criteria
The Sponsor reserves the right to discontinue the trial prior to inclusion of the intended number 
of subjects. After such a decision, the Investigator must contact all participating subjects within a 
time period set by the Sponsor. In the unlikely event of premature termination or discontinuation 
of the study, in the event the Investigator believes a subject is continuing to receive clinical 
benefit, the Sponsor will discuss options with the Investigator in order to ensure continuing 
supply of sacituzumab govitecan.
As directed by the Sponsor’s designee, all study materials will be collected and all eCRFs 
completed to the greatest extent possible.


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13.
DISSEMINATION AND PUBLICATION OF RESULTS
The conditions regulating dissemination of the information derived from this clinical study are 
described in the Clinical Trial Agreement.


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14.
REFERENCES
Bardia A, Diamond JR, Vahdat LT, Tolaney SM, O'Shaughnessy J, Moroose RL, et al. Efficacy 
of sacituzumab govitecan (anti-Trop-2-SN-38 antibody-drug conjugate) for 
treatment-refractory hormone-receptor positive (HR+)/HER2-metastatic breast 
cancer (mBC). J Clin Oncol 2018;36 (15_Suppl):1004.
CAMPTOSAR, Pfizer. CAMPTOSAR (Irinotecan) Injection, intravenous infusion. U.S. 
Prescribing Information. Japan. Revised December.  2014:
Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Arrojo R, Liu D, et al. Sacituzumab 
Govitecan (IMMU-132), an Anti-Trop-2/SN-38 Antibody-Drug Conjugate: 
Characterization and Efficacy in Pancreatic, Gastric, and Other Cancers. 
Bioconjug Chem 2015;26 (5):919-31.
Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Goldenberg DM. Humanized anti-Trop-2 
IgG-SN-38 conjugate for effective treatment of diverse epithelial cancers: 
preclinical studies in human cancer xenograft models and monkeys. Clin Cancer 
Res 2011;17 (10):3157-69.
Cortes J, Dieras V, Ro J, Barriere J, Bachelot T, Hurvitz S, et al. Afatinib alone or afatinib plus 
vinorelbine versus investigator's choice of treatment for HER2-positive breast 
cancer with progressive brain metastases after trastuzumab, lapatinib, or both 
(LUX-Breast 3): a randomised, open-label, multicentre, phase 2 trial. Lancet 
Oncol 2015;16 (16):1700-10.
Cristofanilli M, DeMichele A, Giorgetti C, Turner NC, Slamon DJ, Im SA, et al. Predictors of 
prolonged benefit from palbociclib plus fulvestrant in women with endocrine-
resistant hormone receptor-positive/human epidermal growth factor receptor 2-
negative metastatic breast cancer in PALOMA-3. Eur J Cancer 2018;104:21-31.
Goldenberg DM, Cardillo TM, Govindan SV, Rossi EA, Sharkey RM. Trop-2 is a novel target 
for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-
drug conjugate (ADC). Oncotarget 2015;6 (26):22496-512.
Gray JE, Heist RS, Starodub AN, Camidge DR, Kio EA, Masters GA, et al. Therapy of Small 
Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug 
Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. Clin Cancer Res 
2017;23 (19):5711-9.
Harb WA. Management of patients with hormone receptor-positive breast cancer with visceral 
disease: challenges and treatment options. Cancer management and research 
2015;7:37-46.


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Heist RS, Guarino MJ, Masters G, Purcell WT, Starodub AN, Horn L, et al. Therapy of 
Advanced Non-Small-Cell Lung Cancer With an SN-38-Anti-Trop-2 Drug 
Conjugate, Sacituzumab Govitecan. J Clin Oncol 2017;35 (24):2790-7.
Hortobagyi GN, Smith TL, Legha SS, Swenerton KD, Gehan EA, Yap HY, et al. Multivariate 
analysis of prognostic factors in metastatic breast cancer. J Clin Oncol 1983;1 
(12):776-86.
Jones S, Winer E, Vogel C, Laufman L, Hutchins L, O'Rourke M, et al. Randomized comparison 
of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. 
J Clin Oncol 1995;13 (10):2567-74.
Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, et al. Phase III open-label 
randomized study of eribulin mesylate versus capecitabine in patients with locally 
advanced or metastatic breast cancer previously treated with an anthracycline and 
a taxane. J Clin Oncol 2015;33 (6):594-601.
Maurer W, Bretz F. Multiple testing in group sequential trials using graphical approaches. 
Statistics in biopharmaceutical research 2013;5 (4):311-20.
Ocean AJ, Starodub AN, Bardia A, Vahdat LT, Isakoff SJ, Guarino M, et al. Sacituzumab 
govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the 
treatment of diverse epithelial cancers: Safety and pharmacokinetics. Cancer 
2017;123 (19):3843-54.
Perez EA, Moreno-Aspitia A, Aubrey Thompson E, Andorfer CA. Adjuvant therapy of triple 
negative breast cancer. Breast Cancer Res Treat 2010a;120 (2):285-91.
Perez EA, Patel T, Moreno-Aspitia A. Efficacy of ixabepilone in ER/PR/HER2-negative (triple-
negative) breast cancer. Breast Cancer Res Treat 2010b;121 (2):261-71.
Setiawan VW, Monroe KR, Wilkens LR, Kolonel LN, Pike MC, Henderson BE. Breast cancer 
risk factors defined by estrogen and progesterone receptor status: the multiethnic 
cohort study. Am J Epidemiol 2009;169 (10):1251-9.
Sledge GW, Jr., Toi M, Neven P, Sohn J, Inoue K, Pivot X, et al. MONARCH 2: Abemaciclib in 
Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast 
Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol 
2017;35 (25):2875-84.
Tagawa ST, Faltas B, Saylor P, Bardia A, Hajdenberg J, Morgans A, et al. Sacituzumab 
govitecan (IMMU-132) for patients with pretreated metastatic urothelial uancer 
(UC): interim results [ABSTRACT]. Ann Oncol 2017;28 (5):301-2.


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Twelves C, Awada A, Cortes J, Yelle L, Velikova G, Olivo MS, et al. Subgroup Analyses from a 
Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus 
Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer. 
Breast Cancer: Basic and Clinical Research 2016;10:77-84.


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15.
APPENDICES
Appendix 1.
Signature Page .........................................................................................................................88
Appendix 2.
ECOG Performance Status Evaluation....................................................................................89
Appendix 3.
Procedure for Collection, Storage, and Shipment of Blood and Tissue Samples....................90
Appendix 4.
Schedule of Procedures/Assessments......................................................................................91
Appendix 5.
Quality of Life Questionnaires ................................................................................................96
Appendix 6.
RECIST 1.1 ...........................................................................................................................104
Appendix 7.
Child-Pugh Score in Subjects with Hepatic Impairment.......................................................107
Appendix 8.
Medications Affecting QT Interval .......................................................................................108
Appendix 9.
UGT1A1 Inducers and Inhibitors..........................................................................................110
Appendix 10.
Pandemic Risk Assessment and Mitigation Plan ..................................................................111


Gilead Sciences, Inc. (lmmunomedics, Inc. is now part of the Gilead group of companies) 
Sacituzumab Govitecan 
Protocol IMMU-132-09 
Appendix 1. 
Signature Page 
GILEAD SCIENCES, INC. 
Amendment 7 
(IMMUNOMEDICS, INC. IS NOW PART OF THE GILEAD GROUP OF COMPANIES) 
333 LAKESIDE DRIVE 
FOSTER CITY, CA 94404 
STUDY ACKNOWLEDGMENT 
Product: 
IMMU-132 (sacituzumab govitecan) 
Protocol Number: 
IMMU-132-09 
Protocol Title: 
Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus 
Treatment of Physician's Choice (TPC) in subjects with Hormonal 
Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 
2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed 
at least two prior chemotherapy regimens 
IND #: 122694 
EudraCT Number: 2018-004201-33 
Approval Signature 
Medical Monitor 
Senior Director, Clinical Development 
PPD 
CONFIDENTIAL 
Page 88 
23 August 2021 


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Appendix 2.
ECOG Performance Status Evaluation
ECOG PERFORMANCE STATUS
0 - Fully active, able to carry on all pre-disease performance without restriction
1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary 
nature, e.g., light housework, office work
2 - Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 
50% of waking hours
3 - Capable of only limited self-care; confined to bed or chair more than 50% of waking hours
4 - Completely disabled; cannot carry on any self-care; totally confined to bed or chair
5 - Dead


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Appendix 3.
Procedure for Collection, Storage, and Shipment of Blood and Tissue 
Samples
Instructions for collection, storage, and shipping of samples to be provided in a separate Eurofins 
laboratory instruction manual and Flow Chart prepared for this study. Samples being referred to 
are as follows:

Serum samples for PK

Serum samples for immunogenicity/ADA

Blood samples for UGT1A1 genotyping

Archived biopsy/surgical tissue sample tumor block or a minimum of 6 freshly sectioned 
unstained slides (at a thickness of 5 microns)

Blood samples for biomarker analysis


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Appendix 4.
Schedule of Procedures/Assessments
Phase
Pre-randomization Phase
Randomization Phase
Period
Treatment Period
F/U 
Period
Screening
Baseline w
Cycle 1
Cycle 2+ through last 
cycle
End of 
Treatment 
(EOT)
Follow-upv
Day
-28 to -3
-3 to Day 1
Day 1
Day 8 j
Day 1
Day 8 j
+30 days of 
final treatment
Every 12 
wks ±1wk
Assessments a
Informed consent
X
Inclusion/exclusion criteria
X
Demographics /Reproductive 
Status 
X
Medical/surgical history 
X
Prior anticancer therapy
X
Prior radiation therapy
X
Histology review to confirm 
HR+/HER2- (local) 
X
Tissue sampleb
X
ECOG 
X
X
X
X
Vital signs c
X
X
X
X
X
X
X
Serum pregnancy testd
X
X
X
Weight 
X
X
Physical examination e
X
X
X
X
X
ECG f
X
X
Hematology g 
X
X
X
X
X
X
X


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Phase
Pre-randomization Phase
Randomization Phase
Period
Treatment Period
F/U 
Period
Screening
Baseline w
Cycle 1
Cycle 2+ through last 
cycle
End of 
Treatment 
(EOT)
Follow-upv
Day
-28 to -3
-3 to Day 1
Day 1
Day 8 j
Day 1
Day 8 j
+30 days of 
final treatment
Every 12 
wks ±1wk
Chemistry g
X
X
X
X
X
Uracil level h
X
Urinalysis i
X
Hepatitis B surface antigen, 
Hepatitis C antibody tests 
X
IMMU-132 Only
UGT1A1 sample 
X
Biomarker samples k
X
X
X
PK samples l
X
X
X
Immunogenicity/ADA samples m
X
X
X
QOL assessments n
X
X 
X o
Randomization p
X
Sacituzumab govitecan 
administration q
X
X
X
X
TPC administration r
As per standard of care
CT or MRI tumor assessments s
X
Every 6 weeks for 54 weeks, then every 12 weeks
Xx
Xr
CT or MRI of brain if known or 
suspected brain metastases
X
As clinically indicated or to confirm CR
Xx
Bone scan or 18F-NaF/FDG PET 
scan t
X


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Phase
Pre-randomization Phase
Randomization Phase
Period
Treatment Period
F/U 
Period
Screening
Baseline w
Cycle 1
Cycle 2+ through last 
cycle
End of 
Treatment 
(EOT)
Follow-upv
Day
-28 to -3
-3 to Day 1
Day 1
Day 8 j
Day 1
Day 8 j
+30 days of 
final treatment
Every 12 
wks ±1wk
AEs/SAEs u
X
X
X
X
X
X
X
Prior medications
X
X
Concomitant medications
X
X
X
X
X
Survival
X
ADA = antidrug antibodies; AE = adverse event; ANC = absolute neutrophil count; C1D1 = cycle 1 day 1; C2D1 = cycle 2 day 1; CR = complete remission; CT = computed 
tomography; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; FFPE = formalin fixed paraffin embedded; F/U = follow-up; HER2- = human epidermal 
growth factor receptor 2 negative; HR+ = hormone receptor positive; IV = intraveneous; MRI = magnetic resonance imagining; PD = progressive disease; PET = positron emission 
tomography; PK = pharmacokinetics; PRO-CTCAETM = Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; QOL = quality of life; SAE 
= serious adverse event; TPC = treatment of physician’s choice.
a
Assessments and visit schedule here are specific for Investigational Arm A. For subjects in Control Arm B, please follow TPC specific visit schedule footnotes.
b
Archival tumor tissue FFPE block preferably within 12 months prior to consent or newly acquired biopsy (FFPE block) from a metastatic site. Note: Bone biopsies are not 
allowed. Tumor tissue must be submitted to the Sponsor’s central laboratory by Cycle 2 Day 1, but analysis results are not required from the central laboratory prior to 
enrollment.
c
Vital signs (heart rate, systolic and diastolic blood pressure, respiratory rate, and body temperature) For sacituzumab govitecan arm, required at baseline and on C1D1: prior 
to infusion, 30 minutes after initiation and 30 minutes after completion of infusion. All future visits will require vital signs to be obtained 5-10 min. prior to initiation and at 
the end of the infusion. For subjects receiving TPC, required prior to, once during, and at the end of each infusion, or if administered PO, once at each study visit; otherwise as 
per local standard of care. For TPC infusions less than 10 minutes, vital signs may be obtained before and after infusion. Time points can be ±15 minutes
d
A serum β-hCG test will be performed for premenopausal women and postmenopausal women who have been amenorrheic for less than 12 months.
e
Physical examination including weight required on Day 1 of all cycles for sacituzumab govitecan and at start of each cycle for TPC. Sacituzumab govitecan dosing is based 
on subject’s body weight on Day 1 of each cycle or at each dosing day if change in body weight is > 10% from last measurement or if required by institutional policy. Dose 
modifications for changes in body weight ≤ 10% may be made according to local institutional guidelines. TPC dosing is based upon body surface area as per local standard of 
care. Post-screening physical examinations may be targeted based on findings present at screening or subject complaints.
f
A 12-lead ECG will be obtained at baseline for all subjects. For Arm A only, additional ECGs obtained at C1D1 prior to infusion and 3 hours post finalization of infusion 
±15 minutes. Abnormal findings should be evaluated as clinically indicated, including repeated ECGs. ECGs may be done for all subjects at other time points during the study 
if clinically indicated.


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g
Hematology/chemistry laboratory assessments drawn at Screening and Baseline on all subjects. For subjects receiving sacituzumab govitecan, complete blood count (CBC) 
will be obtained each treatment day. For subjects receiving TPC, CBC and serum chemistries will be obtained at least on the first treatment day of each cycle and as per 
standard of care on other treatment days or study visits (blood draws at anticipated nadir). To be obtained more frequently at the discretion of the managing physician. Results 
must be reviewed prior to every cycle. See Section 7.6.4 for a list of assessments. Assessments must be reviewed prior to dosing and may be performed within 48 hours before 
the scheduled visit. Hematology laboratory assessment includes CBC and differential.
h
Drawn at screening on all subjects eligible to be randomized to the TPC capecitabine arm. If required per local guidelines (please refer to 
https://www.has-sante.fr/portail/upload/docs/application/pdf/2019-01/inahta_brief_dpd_5fu.pdf)
i
Urinalysis will be assessed at the Screening Visit. Urinalysis will include glucose, ketones, pH, protein, white blood cells, hemoglobin (or red blood cells), specific gravity, 
and microscopy. Microscopic examination to be performed only if there are positive findings for blood, protein, leukocytes, or nitrite on the dipstick analysis. If urinalysis 
suggests a urinary tract infection or if clinically indicated, culture and sensitivity should be performed at the institution’s laboratory.
j
If Day 15 is administered, follow Day 8 assessments.
k
Blood samples for biomarkers will be collected at Baseline, pre-dose on C2D1, and at the End of Treatment (EOT)
l
Sactituzumab govitecan only: serum samples for PK will be collected pre-dose and 30 minutes post end of infusion ±15 minutes on Day 1 of Cycles 1, 3, 5, 7, 9, 11 and every 
3 cycles thereafter (e.g., 14, 17, etc.), and at EOT visit and at 3hr post end of infusion on C1D1 ±15 minutes.
m
Sactituzumab govitecan only: serum samples for immunogenicity/ADA analysis will be collected pre-dose on Day 1 of Cycles 1, 3, 5, 7, 9, 11 and every 3 cycles thereafter 
(e.g., 14, 17, etc.), and at EOT visit.
n
QOL assessments include: EORTC QLQ-C30 and EuroQOL EQ-5D-5L instruments, and 9 questions from the PRO-CTCAETM item library.
o
QOL assessments are to be evaluated at the End of Treatment visit prior to telling subjects that they are being withdrawn from the study treatment.
p
Randomization must occur on or before C1D1, such that dosing commences within 5 days after randomization.
q
Sacituzumab govitecan administered on Day 1 and Day 8 of a 21-day cycle (window of ±2 days from the scheduled cycle day). See Section 6.1.7.2.3 for when sacituzumab 
govitecan should be administered based on ANC.
r
For TPC agents: Recommended doses and schedules as per local package insert or NCCN guidelines with dose/schedule modifications per institutional dosing practices.
s
Screening tumor assessments using CT/MRI of the chest, abdomen, and pelvis and other areas of known disease or newly suspected disease should be performed within 
28 days prior to C1D1. (Historical CT/MRI scans performed within 28 days before C1D1 may be used as screening scans to demonstrate eligibility by local radiology review 
as long as they meet minimum standards as separately defined by the central imaging vendor). Scans of the abdomen, pelvis, and other areas of the body may be done with 
MRI instead of CT, but evaluation of the chest should be done with CT. CT scans should be performed with oral and iodinated IV contrast and MRI scans with IV gadolinium 
chelate unless there is a medical contraindication to contrast. Tumor assessments of the chest, abdomen, and pelvis and other areas where scans were performed at screening 
or newly suspected disease should be performed every 6 weeks ±1 week after the start of study treatment (or sooner if there is evidence of PD) through 54 weeks, then every 
12 weeks ±1 week until the occurrence of progression of disease and should use the same methodology (CT or MRI) and scan acquisition techniques (including use or nonuse 
of IV contrast) as were used for the screening assessments. Objective responses must be confirmed ≥ 4 weeks later (e.g., generally at the next tumor assessment time point). 
Subjects who discontinue treatment prior to progression will move to the Follow-up Period and continue with radiologic response assessments every 12 weeks (± 1 week) , 
until progression of disease or initiation of new therapy. During the Treatment Period, CT/MRI of the brain will be performed if clinically indicated, and within a target of 
1 week after a subject achieves a CR. For subjects with history of treated brain metastases, brain scans will be performed at tumor assessment time points if clinically 
indicated. The same methodology and scan acquisition techniques used at Screening should be used throughout the study to ensure comparability.
t
A bone scan (99m-technetium polyphosphonate scintigraphy, whole body bone MRI, or 18F-NaF/FDG PET) to assess bone metastases will be performed within 6 weeks 
prior to C1D1 (historical scans are acceptable). In subjects whose body CT/MRI scans indicate CR has been achieved, a bone scan or 18F-NaF/FDG PET will be required at 
confirmation of CR to exclude new bone metastases or if clinically indicated and within a target of 1 week, but no more than 2 weeks following a CR as assessed by the 
Investigator. The same methodology and acquisition techniques used at Screening should be used throughout the study to ensure comparability. Lesions detected on bone 
scans must be followed with cross-sectional imaging.
u
The safety reporting period begins when the subject signs the informed consent and continues until 30 days after the last dose of study drug. During the period after informed 
consent has been obtained and before the first dose of study drug has been administered, only SAEs caused by a protocol-mandated intervention (e.g., biopsy) should be 
reported. Any SAE that occurs after the safety reporting period and is assessed as possibly related to study drug must be reported according to the instructions in Section 7.6.6. 
All SAEs should be followed to resolution or, if resolution is unlikely, to stabilization.


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v
Subjects will enter the Follow-up Period after completing the EOT Visit. During the Follow-up Period, subjects may be treated according to local standard of care. Subjects 
will be contacted every 12 weeks (±1 week) for survival status and subsequent anticancer treatment received. Subjects who discontinue study treatment prior to disease 
progression will have EOT visit and continue in the Follow-Up Period with radiologic response assessments every 12 weeks (±1 week) until disease progression or initiation 
of new therapy. At that time these subjects will then be contacted for survival status and subsequent anticancer treatment received.
w
Baseline assessment must be completed prior to C1D1 dosing
x
Only to be performed if radiologic progression has not been already confirmed by RECIST 1.1.


Gilea d Scie nces, I nc. (I m m u n o me dics, I nc. is n o w part of t he Gilea d gr o u p of c o m pa nies)
Sacit uz u ma b G o viteca n
Pr ot oc ol I M M U- 1 3 2- 0 9
A me n d me nt 7
C O N FI D E N TI A L
Pa ge 9 6
2 3 A u g ust 2 0 2 1
A p pe n di x 5.  
Q u alit y of Life Q uesti o n n aires
E O R T C Q L Q- C 3 0 ( versi o n 3)
We are i ntereste d i n s o me t hi n gs a b o ut y o u a n d y o ur healt h. Please a ns wer all of t he q uesti o ns 
y o urself b y circli n g t he n u m ber t hat best a p plies t o y o u. T here are n o "ri g ht" or " wr o n g" 
a ns wers. T he i nf or mati o n t hat y o u pr o vi de will re mai n strictl y c o nfi de ntial.
Please fill i n y o ur i nitials:

Y o ur birt h date ( Da y, M o nt h, Year):

T o da y's date ( Da y, M o nt h, Year): 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
N ot at 
All
A 
Little
Q uite a 
Bit
Ver y 
M uc h
1.
D o y o u ha ve a n y tr o u ble d oi n g stre n u o us acti vities,
li ke carr yi n g a hea v y s h o p pi n g ba g or a s uitcase?
1 
2 
3
4
2.
D o y o u ha ve a n y tr o u ble ta ki n g a l o n g wal k?
1 
2 
3
4
3.
D o y o u ha ve a n y tr o u ble ta ki n g a s h ort wal k o utsi de of t he h o use? 
1 
2 
3
4
4.
D o y o u nee d t o sta y i n be d or a c hair d uri n g t he da y?
1 
2 
3
4
5.
D o y o u nee d hel p wit h eati n g, dressi n g, was hi n g
y o urself or usi n g t he t oilet?
1 
2 
3
4
D uri n g t he p ast wee k:
6.
Were y o u li mite d i n d oi n g eit her y o ur w or k or ot her dail y acti vities?
1 
2 
3
4
7.
Were y o u li mite d i n p urs ui n g y o ur h o b bies or ot her
leis ure ti me acti vities?
1 
2 
3
4
8.
Were y o u s h ort of breat h?
1 
2 
3
4
9.
Ha ve y o u ha d pai n?
1 
2 
3
4
1 0.
Di d y o u nee d t o rest?
1 
2 
3
4
1 1.
Ha ve y o u ha d tr o u ble slee pi n g?
1 
2 
3
4
1 2.
Ha ve y o u felt wea k?
1 
2 
3
4


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13. Have you lacked apetite?
1
2
3
4
14. Have you felt nauseated?
1
2
3
4
15. Have you vomited?
1
2
3
4
16. Have you ben constipated?
1
2
3
4
17. Have you had diarhea?
1
2
3
4
18. Were you tired?
1
2
3
4
19. Did pain interfere with your daily activities?
1
2
3
4
20. Have you had dificulty in concentrating on things,
like reading a newspaper or watching television?
1
2
3
4
21. Did you fel tense?
1
2
3
4
2. Did you wory?
1
2
3
4
23. Did you fel iritable?
1
2
3
4
24. Did you fel depresed?
1
2
3
4
25. Have you had dificulty remembering things?
1
2
3
4
26. Has your physical condition or medical treatment
interfered with your family life?
1
2
3
4
27. Has your physical condition or medical treatment
interfered with your social activities?
1
2
3
4
28. Has your physical condition or medical treatment
caused you financial dificulties?
1
2
3
4
For the following questions please circle the number between 1 and 7 that 
best applies to you
29.
How would you rate your overal health during the past wek?
1
2
3
4
5
6
7
 Very por 
Excelent


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30.
How would you rate your overall quality of life during the past week?
1
2
3
4
5
6
7
 Very poor 
Excellent


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Under each heading, please tick the ONE box that best describes yow- health TODAY. 
MOBILITY 
I have no problems in walking about 
I have slight problems in walking about 
I have moderate problems in walking about 
I have severe problems in walking about 
I am unable to walk about 
SELF-CARE 
I have no problems washing or dressing myself 
I have slight problems washing or dressing myself 
I have moderate problems washing or dressing myself 
I have severe problems washing or dressing myself 
I am unable to wash or dress myself 
D 
D 
USUAL ACTIVITIES (e.g., work, study, housework, family or leisure activities) 
I have no problems doing my usual activities 
I have slight problems doing my usual activities 
I have moderate problems doing my usual activities 
I have severe problems doing my usual activities 
I am unable to do my usual activities 
PAIN I DISCOMFORT 
I have no pain or discomfo1t 
I have slight pain or discomfort 
I have moderate pain or discomf 01t 
I have severe pain or discomf 01t 
I have extreme pain or discomfo1t 
ANXIETY / DEPRESSION 
I am not anxious or depressed 
CONFIDENTIAL 
Page 99 
23 August 2021 


Gilea d Scie nces, I nc. (I m m u n o me dics, I nc. is n o w part of t he Gilea d gr o u p of c o m pa nies)
Sacit uz u ma b G o viteca n
Pr ot oc ol I M M U- 1 3 2- 0 9
A me n d me nt 7
C O N FI D E N TI A L
Pa ge 1 0 0
2 3 A u g ust 2 0 2 1
I a m sli g htl y a n xi o us or de presse d

I a m m o deratel y a n xi o us or de presse d

I a m se verel y a n xi o us or de presse d

I a m e xtre mel y a n xi o us or de presse d


We w o ul d li ke t o k n o w h o w g o o d or ba d y o ur healt h is T O D A Y.

T his scale is n u m bere d fr o m 0 t o 1 0 0.

1 0 0 mea ns t he best healt h y o u ca n i ma gi ne. 0 mea ns t he w orst 
healt h y o u ca n i ma gi ne.

Mar k a n X o n t he scale t o i n dicate h o w y o ur healt h is T O D A Y.

N o w, please write t he n u m ber y o u mar ke d o n t he scale i n t he b o x 
bel o w.
Y O U R H E A L T H T O D A Y =
T h e b est hea' hh 
- 1 0 0 
9 5 
9 0 
8 5 
8 0 
7 5 
70 
6 5 
6 0 
5 5 
5 0 
~ 5 
~o 
3 5 
3 0 
2 5 
2 0 
1 5 
1 0 
5 
0 
yo 11 c:an i n~ - e 


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NCI PRO-CTCAE™ ITEMS
Item Library Version 1.0
Form created on 20 November 2018
As individuals go through treatment for their cancer they sometimes experience different 
symptoms and side effects. For each question, please check or mark an 
 in the one box 
that best describes your experiences over the past 7 days.
Q9 


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In the last 7 days, what was the SEVERITY of your DECREASED APPETITE at its 
WORST?
○None
○Mild
○Moderate
○Severe
○Very severe
In the last 7 days, how much did DECREASED APPETITE INTERFERE with your 
usual or daily activities?
1.
○Not at all
○A little bit
○Somewhat
○Quite a bit
○Very much
In the last 7 days, how OFTEN did you have NAUSEA?
○Never
○Rarely
○Occasionally
○Frequently
Almost con- 
stantly
In the last 7 days, what was the SEVERITY of your NAUSEA at its WORST?
2.
○None
○Mild
○Moderate
○Severe
○Very severe
In the last 7 days, how OFTEN did you have VOMITING?
○Never
○Rarely
○Occasionally
○Frequently
Almost con- 
stantly
In the last 7 days, what was the SEVERITY of your VOMITING at its WORST?
3.
○None
○Mild
○Moderate
○Severe
○Very severe
In the last 7 days, what was the SEVERITY of your CONSTIPATION at its WORST?
4.
○None
○Mild
○Moderate
○Severe
○Very severe
In the last 7 days, how OFTEN did you have LOOSE OR WATERY STOOLS 
(DIARRHEA/DIARRHOEA)?
5.
○Never
○Rarely
○Occasionally
○Frequently
Almost con-
 stantly
In the last 7 days, how OFTEN did you have PAIN IN THE ABDOMEN (BELLY 
AREA)?
○Never
○Rarely
○Occasionally
○Frequently
Almost con- 
stantly
In the last 7 days, what was the SEVERITY of your PAIN IN THE ABDOMEN (BELLY 
AREA) at its WORST?
○None
○Mild
○Moderate
○Severe
○Very severe
In the last 7 days, how much did PAIN IN THE ABDOMEN (BELLY AREA) 
INTERFERE with your usual or daily activities?
6.
○Not at all
○A little bit
○Somewhat
○Quite a bit
○Very much
In the last 7 days, what was the SEVERITY of your SHORTNESS OF BREATH at its 
WORST?
7.
○None
○Mild
○Moderate
○Severe
○Very severe


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In the last 7 days, how much did your SHORTNESS OF BREATH INTERFERE with 
your usual or daily activities?
○Not at all
○A little bit
○Somewhat
○Quite a bit
○Very much
In the last 7 days, did you have any HAIR LOSS?
8.
○Not at all
○A little bit
○Somewhat
○Quite a bit
○Very much
In the last 7 days, what was the SEVERITY of your FATIGUE, TIREDNESS, OR 
LACK OF ENERGY at its WORST?
○None
○Mild
○Moderate
○Severe
○Very severe
In the last 7 days, how much did FATIGUE, TIREDNESS, OR LACK OF ENERGY 
INTERFERE with your usual or daily activities?
9.
○Not at all
○A little bit
○Somewhat
○Quite a bit
○Very much
I 
I 
I 
I 
I 
I 
I 
I 
I 
I 
I 
I 
I 
I 
I 
I 


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Appendix 6.
RECIST 1.1
New RECIST: Revised RECIST criteria are summarized below. Timing of assessments has been 
modified to fit this protocol.
Measurable/Nonmeasurable Lesions. Each tumor lesion or site of disease identified at baseline 
is categorized as either a measurable lesion or a nonmeasurable lesion according to the following 
definitions. 
Lesion Type
Qualifying Definition
Measurable
Tumor lesions: Must be accurately measured in at least one dimension (longest diameter 
in the plane of measurement is to be recorded) with a minimum size of: • 10 mm by CT 
scan (CT scan slice thickness no greater than 5 mm.) • 10 mm caliper measurement by 
clinical exam (lesions which cannot be accurately measured with calipers should be 
recorded as nonmeasurable) • 20 mm by chest X-ray.
Malignant LNs: To be considered pathologically enlarged and measurable, a LN must be 
15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to 
be no greater than 5 mm). At baseline and in follow-up, only the short axis will be 
measured and followed.
Non-Measurable
All other lesions, including small lesions (longest diameter <10 mm or pathological LNs 
with 10 to <15 mm short axis) as well as truly nonmeasurable lesions. Lesions considered 
truly nonmeasurable include: leptomeningeal disease, ascites, pleural or pericardial 
effusion, inflammatory breast disease, lymphangitic involvement of skin or lung, 
abdominal masses/abdominal organomegaly identified by physical examination that is not 
measurable by reproducible imaging techniques.
Source: https://recist.eortc.org/recist-1-1-2/
LN = lymph node
Special considerations regarding lesion measurability
Bone lesions, cystic lesions, and lesions previously treated with local therapy require particular 
comment as follows:

Bone lesions:
Bone scan, (99m-technetium polyphosphonate scintigraphy, whole body bone MRI, or 
18F-NaF / FDG PET) scan or plain films are not considered adequate imaging techniques 
to measure bone lesions. However, these techniques can be used to confirm the presence 
or disappearance of bone lesions.
Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, 
that can be evaluated by cross-sectional imaging techniques such as CT or MRI, can be 
considered as measurable lesions if the soft tissue component meets the definition of 
measurability described above.
Blastic bone lesions are nonmeasurable.


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
Cystic lesions:
Lesions that meet the criteria for radiographically defined simple cysts should not be 
considered as malignant lesions (neither measurable nor nonmeasurable) since they are, 
by definition, simple cysts.
Cystic lesions’ thought to represent cystic metastases can be considered as measurable 
lesions, if they meet the definition of measurability described above. However, if 
noncystic lesions are present in the same subject, these are preferred for selection as 
target lesions.

Lesions with prior local treatment. Tumor lesions situated in a previously irradiated area or in 
an area subjected to other loco-regional therapy are usually not considered measurable unless 
there has been demonstrated progression in the lesion.
Note: All measurements should be recorded in metric notation using calipers if clinically 
assessed. All Baseline evaluations should be performed as close as possible to the treatment start 
and never more than 28 days before the beginning of the treatment.
Target Lesions
Target lesions are selected from measurable lesions at baseline on the basis of their size and 
suitability for accurate repeated measurements by imaging techniques or clinical judgment. The 
sum of the longest diameter (LD) for all target lesions provides a quantitative means of 
characterizing objective tumor response to treatment as follows:
Evaluation Criteria Used for Categorizing Treatment Response of Target Lesions
Response Category
Definition
CR
Disappearance of all target lesions
PR
> 30% decrease in the sum of the LD of target lesions, taking as reference the 
baseline sum LD
PD
> 20% increase in the sum of the LD of target lesions and a 5 mm absolute increase, 
taking as reference the smallest sum LD recorded since the baseline assessment or 
the appearance of one or more new lesions.
SD
Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for 
PD, taking as reference the smallest sum LD since the treatment started
CR=complete response; PD=progressive disease; PR=partial response; SD=stable disease
Non-Target Lesions
Non-target lesions are other lesions (or sites of disease) not identified as target lesions at 
baseline. These include both nonmeasurable lesions as well as measurable lesions exceeding the 
maximum number allowed per organ or in total. The response of non-target lesions to treatment 
is evaluated on the basis of their presence or absence as follows: 


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Evaluation Criteria Used for Categorizing Treatment Response of Non-Target Lesions
Response Category
Definition
CR
Disappearance of all non-target lesions and normalization of tumor marker levels 
initially above upper limits of normal
PD
Appearance of one or more new lesions and/or unequivocal progression of 
existing non-target lesions
Incomplete Response/SD
Persistence of one or more non-target lesion(s) or/and maintenance of tumor 
marker level above the normal limits
CR=complete response; PD=progressive disease; SD=stable disease
New Lesions
New lesions not present at baseline should be recorded at time of occurrence.
Overall Response
Overall response is the best response recorded from the start of the treatment until disease 
progression/recurrence (taking as reference for PD the smallest measurements recorded since the 
treatment started). To be assigned a status of PR or CR, changes in tumor measurements must be 
confirmed by repeat assessments that should be performed ≥ 4 weeks later according to BICR 
using RECIST 1.1 after the criteria for response are first met. In the case of SD, follow-up 
measurements must have met the SD criteria at least once with a minimum interval of at least 
6-8 weeks from randomization.
Target Lesions
Non-target Lesions
New Lesions
Overall Response
CR
CR
No
CR*
CR
Incomplete response/SD
No
PR
PR
Non-PD
No
PR
SD
Non-PD
No
SD
PD
Any
Yes or No
PD**
Any
PD
Yes or No
PD**
Any
Any
Yes
PD**
*When evaluation of possible CR depends on distinguishing residual disease from normal tissue, fine needle aspirate/biopsy is 
recommended before confirming the complete response status.
**Subjects without objective evidence of disease progression, but with globally deteriorated health status requiring 
discontinuation of treatment should be classified as having “symptomatic deterioration” at that time, with every effort made to 
document the objective progression, even after discontinuation of treatment.
DOR
The duration of overall response is measured from the time measurement criteria are met for CR 
or PR (whichever is first recorded) until the first date that recurrent or PD is objectively 
documented (taking as reference for PD the smallest measurements recorded since the treatment 
started). SD is measured from the start of the treatment until the criteria for progression are met, 
taking as reference the smallest measurements recorded since the treatment started.


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Appendix 7.
Child-Pugh Score in Subjects with Hepatic Impairment 
Modified Child-Pugh Score
Manifestation
One point
Two points
Three points
Encephalopathya
None
Grade I–II
Grade III–IV
Ascites
Absent
Nontense
Tense
Bilirubin (mg/dl)
Noncholestatic
Cholestatic
< 2
< 4
2–3
4–10
> 3
> 10
Albumin (g/dl)
> 3.5
2.8–3.5
< 2.8
INR (International normalized ratio)
< 1.7
1.7–2.3
> 2.3
a
Encephalopathy: I, mild confusion or slowing, no asterixis; II, drowsy, asterixis present; III, marked confusion, somnolence, 
asterixis present; IV, unresponsive or responsive only to painful stimuli, no asterixis.
Class A, 5– 6 points
Class B, 7–9 points
Class C, >10 points
Table adapted from Superfin D, Iannucci AA, Davies AM. Commentary: Oncologic drugs in patients with organ dysfunction: A 
summary. The Oncologist 2007;12:1070-1083.


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Appendix 8.
Medications Affecting QT Interval
Medications Affecting QT Interval
Abarelix (PR)
Aclarubicin (KR)
Alfuzosin (PR)
Alimemazine
(trimeprazine) (PR)
Amantadine (CR)
Amiodarone (KR)
Amisulpride (CR)
Amitriptyline (CR)
Amphotericin B (CR)
Amsacrine (acridinyl 
anisidide) (CR)
Anagrelide (KR)
Apalutamide (PR)
Apomorphine (PR)
Aripiprazole (PR)
Arsenic trioxide (KR)
Artemether + 
Lumefantrine (PR)
Artenimol+piperaquine 
(PR)
Asenapine (PR)
Astemizole (KR)
Atazanavir (CR)
Atomoxetine (PR)
Azithromycin (KR)
Bedaquiline (PR)
Bendamustine (PR)
Bendroflumethiazide
or bendrofluazide (CR)
Benperidol (PR)
Bepridil (KR)
Betrixaban (PR)
Bortezomib (PR)
Bosutinib (PR)
Buprenorphine (PR)
Cabozantinib (PR)
Capecitabine (PR)
Ceritinib (PR)
Chloral hydrate (CR)
Dexmedetomidine (PR)
Dextromethorphan/Quinidine 
(PR)
Diphenhydramine (CR)
Disopyramide (KR)
Dofetilide (KR)
Dolasetron (PR)
Domperidone (KR)
Donepezil (KR)
Doxepin (CR)
Dronedarone (KR)
Droperidol (KR)
Efavirenz (PR)
Eliglustat (PR)
Encorafenib (PR)
Eperisone (CR)
Epirubicin (PR)
Eribulin mesylate (PR)
Erythromycin (KR)
Escitalopram (KR)
Esomeprazole (CR)
Ezogabine (Retigabine) (PR)
Famotidine (CR)
Felbamate (PR)
Fingolimod (PR)
Flecainide (KR)
Fluconazole (KR)
Fluorouracil (5-FU) (PR)
Fluoxetine (CR)
Flupentixol (PR)
Fluvoxamine (CR)
Furosemide (frusemide) 
(CR)
Galantamine (CR)
Garenoxacin (CR)
Gatifloxacin (KR)
Gemifloxacin (PR)
Gilteritinib (PR)
Glasdegib (PR)
Granisetron (PR)
Lacidipine (PR)
Lansoprazole (CR)
Lapatinib (PR)
Lenvatinib (PR)
Leuprolide (Leuprorelin) 
(PR)
Levofloxacin (KR)
Levomepromazine
(methotrimeprazine) 
(KR)
Levomethadyl acetate 
(KR)
Levosulpiride (KR)
Lithium (PR)
Lofexidine (PR)
Loperamide (CR)
Lopinavir and ritonavir 
(PR)
Maprotiline (PR)
Melperone (PR)
Memantine (PR)
Namenda XR
Mesoridazine (KR)
Methadone (KR)
Metoclopramide (CR)
Metolazone (CR)
Metronidazole (CR)
Mianserin (PR)
Midostaurin (PR)
Mifepristone (PR)
Mirabegron (PR)
Mirtazapine (PR)
Moexipril/HCTZ (PR)
Moxifloxacin (KR)
Necitumumab (PR)
Nelfinavir (CR)
Nicardipine (PR)
Nilotinib (PR)
Norfloxacin (PR)
Nortriptyline (PR)
Piperacillin/Tazobactam 
(CR)
Posaconazole (CR)
Primaquine phosphate 
(PR)
Probucol (KR)
Procainamide (KR)
Promethazine (PR)
Propafenone (CR)
Propofol (KR)
Prothipendyl (PR)
Quetiapine (CR)
Quinidine (KR)
Quinine sulfate (CR)
Ranolazine (CR)
Ribociclib (PR)
Rilpivirine (PR)
Risperidone (PR)
Romidepsin (PR)
Roxithromycin (KR)
Saquinavir (PR)
Sertindole (PR)
Sertraline (CR)
Sevoflurane (KR)
Siponimod (PR)
Solifenacin (CR)
Sorafenib (PR)
Sotalol (KR)
Sparfloxacin (KR)
Sulpiride (KR)
Sultopride (KR)
Sunitinib (PR)
Tacrolimus (PR)
Tamoxifen (PR)
Telaprevir (CR)
Telavancin (PR)
Telithromycin (PR)
Terfenadine (KR)
Terlipressin (KR)
Terodiline (KR)


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Medications Affecting QT Interval
Chloroquine (KR)
Chlorpromazine (KR)
Cilostazol (KR)
Cimetidine (CR)
Ciprofloxacin (KR)
Cisapride (KR)
Citalopram (KR)
Clarithromycin (KR)
Clofazimine (PR)
Clomipramine (PR)
Clotiapine (PR)
Clozapine (PR)
Cobimetinib (PR)
Cocaine (KR)
Crizotinib (PR)
Cyamemazine 
(cyamepromazine) (PR)
Dabrafenib (PR)
Dasatinib (PR)
Degarelix (PR)
Delamanid (PR)
Desipramine (PR)
Deutetrabenazine (PR)
Grepafloxacin (KR)
Halofantrine (KR)
Haloperidol (KR)
Hydrochlorothiazide (CR)
Hydrocodone - ER (PR)
Hydroquinidine,
dihydroquinidine (KR)
Hydroxychloroquine (CR)
Hydroxyzine (CR)
Ibogaine (KR)
Ibutilide (KR)
Iloperidone (PR)
Imipramine (melipramine) 
(PR)
Indapamide (CR)
Inotuzumab ozogamicin (PR)
Isradipine (PR)
Itraconazole (CR)
Ivabradine (CR)
Ivosidenib (PR)
Ketanserin (PR)
Ketoconazole (CR)
Nusinersen (PR)
Ofloxacin (PR)
Olanzapine (CR)
Omeprazole (CR)
Ondansetron (KR)
Osimertinib (PR)
Oxaliplatin (KR)
Oxytocin (PR)
Paliperidone (PR)
Palonosetron (PR)
Panobinostat (PR)
Pantoprazole (CR)
Papaverine HCl 
(Intracoronary) (KR)
Paroxetine (CR)
Pasireotide (PR)
Pazopanib (PR)
Pentamidine (KR)
Perflutren lipid 
microspheres (PR)
Perphenazine (PR)
Pilsicainide (PR)
Pimavanserin (PR)
Pimozide (KR)
Pipamperone (PR)
Tetrabenazine (PR)
Thioridazine (KR)
Tiapride (PR)
Tipiracil and 
Trifluridine (PR)
Tizanidine (PR)
Tolterodine (PR)
Toremifene (PR)
torsemide (torasemide) 
(CR)
Tramadol (PR)
Trazodone (CR)
Trimipramine (PR)
Tropisetron (PR)
Valbenazine (PR)
Vandetanib (KR)
Vardenafil (PR)
Vemurafenib (PR)
Venlafaxine (PR)
Voriconazole (CR)
Vorinostat (PR)
Ziprasidone (CR)
Zotepine (PR)
Zuclopenthixol, 
Zuclopentixol (PR)
26-Jun-19website at www.crediblemeds.org as of 26-Jun-19. CredibleMeds® has reviewed available evidence for the drugs on 
the following list and place them in one of three designated categories: Known Risk of TdP (KR), Possible Risk of TdP (PR) or 
have a Conditional Risk of TdP (CR).


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Appendix 9.
UGT1A1 Inducers and Inhibitors
Inducers of UGT1A1
Inhibitors of UGT1A1
Carbamazepine
Efavirenz
Ethinylestradiol
Lamotrigine
Phenobarbital
Phenytoin
Primidone
Rifampicin
Ritonavir
Tipranavir
Amitriptyline
Atazanavir
Dacomitinib
Dasabuvir
Deferasirox
Eltrombopag
Enasidenib
Erlotinib
Flunitrazepam
Flurbiprofen
Fostamatinib
Gemfibrozil
Glecaprevir
Indinavir
Indomethacin
Ketoconazole
Nilotinib
Ombitasvir
Paritaprevir
Pazopanib
Pexidartinib
Pibrentasvir
Probenecid
Propofol
Regorafenib
Rucaparib
Silibinin
Sorafenib
Valproic acid


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Appendix 10.
Pandemic Risk Assessment and Mitigation Plan
During an ongoing pandemic, potential risks associated with patients being unable to attend 
study visits have been identified for this study.
These risks can be summarized as follows:
1) Study drug supplies to patients and sites:
a) Patients may be unable to return to the site for a number of visits to get the study drug, or 
the site may be unable to accept any patient visits. Without study drugs, the patient would 
not be able to continue receiving the study drug as planned per protocol.
Mitigation plan: Study drug supplies may be provided to the patient from the site without 
a clinic visit, once it is confirmed that the patient may safely continue on study drug as 
determined by the principal investigator. A remote study visit, via phone or video 
conferencing, must be performed before remote study drug resupply. At the earliest 
opportunity, the site will schedule in-person patient visits and return to the protocol’s 
regular schedule of assessments. A qualified courier may be utilized to ship the study 
drug from sites to study patients if permitted by the local ethics committee/institutional 
review board/regulatory authority as applicable and with Sponsor's approval.
b) Shipments of study drug could be delayed because of transportation issues. Without study 
drug, the patient would not be able to continue receiving the study drug as planned per 
protocol.
Mitigation plan: The site’s study drug inventory should be closely monitored. Site staff 
should notify the Sponsor or delegate if they foresee shortage in study drug inventory or 
if there is any interruption in local shipping service. The Sponsor will continue to monitor 
inventory at the study drug depot and investigational sites. Manual shipments will be 
triggered as necessary.
2) Patient safety monitoring and follow-up:
a) Patients may be unable or unwilling to come to the investigational site for their scheduled 
study visits as required per protocol.
Mitigation plan: For patients who may be unable or unwilling to visit the investigational 
site for their scheduled study visits as required per protocol, the principal investigator or 
qualified delegate will conduct a remote study visit, via phone or video conferencing, to 
assess the patient within the target visit window date whenever possible. During the 
remote study visit, the following information at minimum will be reviewed:
i)
Confirm if patient has experienced any adverse events (AEs)/serious adverse events 
(SAEs)/special situations (including pregnancy) and follow up on any unresolved 
AEs/SAEs.


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Amendment 7
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ii) Review the current list of concomitant medications and document any new 
concomitant medications.
iii) If applicable, confirm electronic diary questionnaires and patient-reported outcomes 
have been completed and transmitted.
iv) If applicable, confirm the patient’s study drug supply is sufficient to last until the next 
planned visit date. If study drug resupply is needed, it will be provided as described 
above in (1).
v) If applicable, remind the patient to maintain current dosing.
b) Patients may be unable or unwilling to travel to the site for planned assessments (e.g., 
safety blood draws); hence samples may not be sent for central laboratory analyses.
Mitigation plan: Local laboratories or other vendors may be utilized as appropriate to 
monitor patient safety until the patient can return to the site for their regular follow-up 
per protocol. Any changes in the party conducting laboratory assessments for the study 
due to the pandemic will be documented accordingly. Pregnancy testing may be 
performed using a home urine pregnancy test if local laboratory pregnancy testing is not 
feasible.
c) Patients may be unable or unwilling to attend the study visit to sign an updated informed 
consent form version.
Mitigation plan: The site staff will follow their approved consent process and remain in 
compliance with the local ethics committee/institutional review board and national laws 
and regulations. Remote consent will be allowed if it has been approved by the local 
ethics committee/institutional review board. The consent process will be documented and 
confirmed by normal consent procedure at the earliest opportunity.
d) The safety of study patients is important and testing of coronavirus disease 2019 
(COVID-19) infection will be based on local clinical guidelines for testing based on 
signs/symptoms and/or suspected exposure to COVID-19.
Mitigation plan: If patient has a diagnosis of COVID-19 while on this clinical study, 
study drug may be held until clinical improvement or resolution in accordance with the 
treating physician’s judgment and general sacituzumab govitecan (SG) dose delay 
guidance in the protocol. Additional supportive care and treatment measures for 
COVID-19 infection on the study will be performed in accordance with local institutional 
guidelines. Patients with a COVID-19 infection while participating in the clinical study 
will have this event documented as an AE in the clinical database.


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3) Protocol and monitoring compliance:
a) Protocol deviations may occur in case scheduled visits cannot be conducted as planned 
per protocol.
Mitigation plan: If it is not possible to complete a required procedure, an unscheduled 
visit should be conducted as soon as possible when conditions allow. The situation should 
be recorded and explained as a protocol deviation. Any missed patient visits or deviation 
to the protocol due to the pandemic must be reported in the electronic case report form 
and described in the clinical study report. Any remote study visits that are conducted in 
lieu of clinic visits due to the pandemic will be documented as a protocol deviation 
related to the pandemic.
b) Study monitors may be unable to carry out source data review or source data verification, 
or study drug accountability or assess protocol and Good Clinical Practice compliance. 
This may lead to delays in source data verification, an increase in protocol deviations, or 
underreporting of AEs.
Mitigation plan: The study monitor is to remain in close communication with the site to 
ensure data entry and query resolution. Remote source data verification may be arranged 
if allowed by local regulation and the Study Monitoring Plan. The study monitor is to 
reference the Study Monitoring Plan for guidance on how to conduct an off-site 
monitoring visit. The study staff is to save and document all relevant communication in 
the study files. The status of sites that cannot accept monitoring visits and/or patients 
on-site, must be tracked centrally and updated on a regular basis.
4) Missing data and data integrity:
There may be an increased amount of missing data due to patients missing 
visits/assessments. This could have an impact on the analysis and the interpretation of 
clinical study data.
Mitigation plan: Implications of a pandemic on methodological aspects for the study will 
be thoroughly assessed and documented, and relevant actions will be taken as appropriate 
(e.g., modification of the statistical analysis plan) and in compliance with regulatory 
authorities’ guidance. Overall, the clinical study report will describe the impact of the 
pandemic on the interpretability of study data.
5) Concurrent administration of the COVID-19 vaccine:
There may be potential safety issues due to concurrent administration of the COVID-19 
vaccine and study drugs.


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Protocol IMMU-132-09
Amendment 7
CONFIDENTIAL
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Mitigation plan: There is not substantial safety data regarding the concurrent 
administration of the COVID-19 vaccine and SG. Patients are allowed to receive the 
COVID-19 vaccine to reduce the risk and complications of COVID-19 infection. 
Investigators and study personnel should provide close surveillance of patients after 
COVID-19 vaccine administration and the institutional guidelines should always be 
followed. The administration of specific COVID-19 vaccine must be documented in the 
clinical database and AEs associated with COVID-19 vaccine administration should be 
recorded in the AE electronic case report form (eCRF). COVID-19 vaccine 
administration should be recorded in the prior or concomitant medication eCRF as 
appropriate. The study visits should continue as planned, if possible, and clinically 
appropriate if vaccination occurs while the patients is on the study.
Risks will be assessed continuously, and temporary measures will be implemented to mitigate 
these risks as part of a mitigation plan, as described above. These measures will be 
communicated to the relevant stakeholders as appropriate and are intended to provide alternate 
methods that will ensure the evaluation and assessment of the safety of patients who are enrolled 
in this study.
Since these potential risks are considered mitigated with the implementation of these measures, 
the expected benefit-risk assessment of SG in study patients remains unchanged.

SAP_001.pdf: 
STATISTICAL ANALYSIS PLAN
Study Title
Phase 3 Study of Sacituzumab Govitecan (IMMU-132) versus 
Treatment of Physician’s Choice (TPC) in Subjects with Hormonal 
Receptor Positive (HR+) and Human Epidermal Growth Factor 
Receptor 2 Negative (HER2-) Metastatic Breast Cancer (MBC) Who 
Have Failed at least Two Prior Chemotherapy Regimens
Protocol Number:
IMMU-132-09
Protocol Version 
and Date:
21 December 2018 (Original release)
03 July 2019 (Amendment 1)
10 July 2019 (Amendment 2)
04 February 2020 (Amendment 3)
13 March 2020 (Amendment 4)
08 October 2020 (Amendment 5)
27 January 2021 (Amendment 6)
23 August 2021 (Amendment 7)
Investigational 
Product:
sacituzumab govitecan (Company Code: IMMU-132)
Phase:
Phase 3
IND #:
122694
EudraCT Number:
2018-004201-33
Methodology:
Two arms open-label study
Sponsor:
Gilead Sciences, Inc (Immunomedics, Inc. is now part of the 
Gilead group of companies)
333 Lakeside Drive
Foster City, CA 94404
Author:
.
Associate Director, Biostatistics, Gilead Sciences, Inc.
Analysis Plan 
Version:
Version 5.0
CONFIDENTIAL AND PROPRIETARY INFORMATION
PPD
(rJ GILEAU 


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IMMU-132-09 Statistical Analysis Plan
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APPROVAL SIGNATURE PAGE
IMMU-132-09 STATISTICAL ANALYSIS PLAN
Protocol Title:
Phase 3 Study of Sacituzumab Govitecan (IMMU-132) versus 
Treatment of Physician’s Choice (TPC) in Subjects with Hormonal 
Receptor Positive (HR+) and Human Epidermal Growth Factor 
Receptor 2 Negative (HER2-) Metastatic Breast Cancer (MBC) Who 
Have Failed at least Two Prior Chemotherapy Regimens
Protocol Number:
IMMU-132-09
Investigational 
Product:
sacituzumab govitecan (Company Code:  IMMU-132)
Sponsor:
Gilead Sciences, Inc (Immunomedics, Inc. is now part of the 
Gilead group of companies)
333 Lakeside Drive
Foster City, CA 94404
I confirm I have reviewed this SAP and find its content to be acceptable.
Head of Biostatistics Signatory:
Executive Director, Biostatistics
Signature: [See appended signature page]
Date: [See appended signature page]
Clinical Signatory:
 
Clinical Development
Signature: [See appended signature page]
Date: [See appended signature page]
Clinical Pharmacology Signatory:
 
Clinical Pharmacology
Signature: [See appended signature page]
Date: [See appended signature page]
PPD
PPD
PPD


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REVISION HISTORY
Version Number
Version Date
Summary and Rational of Revision(s)
1.0
25JUN2020
Initial version
2.0
08OCT2020
Update sample size to align with Protocol Amendment 5.  Clarify AEOSI 
definitions.  Add sensitivity analysis for interim and for Clinical Benefit 
Rate (CBR)
3.0
03FEB2021
Section 1. Introduction: Update to reference the protocol amendment 6.
Section 2.1. Primary Objective: Changed primary PFS definition from 
determine by LIR to BICR and moved ORR to Secondary Objective to 
align with Protocol Amendment 6.
Section 3.3. Interim Analysis: Clarified interim analysis will not be 
conducted to align with Protocol Amendment 6.
Section 3.4: Multiplicity Adjustment: Clarify alpha spent on PFS and OS 
to align with Protocol Amendment 6.
Section 4.1: Primary Efficacy Endpoint: Update PFS as determined by 
BICR and moved ORR to Secondary Endpoint to align with Protocol 
Amendment 6.  
Table 2: added clarification on analyses and their analyses population to 
align with Protocol Amendment 6.
Section 7.1.1. Progression-Free Survival: Update PFS as determined by 
BICR and added clarification to sensitivity analyses and censoring rules to 
align with Protocol Amendment 6. 
Added a row under “Continued scheduled response assessments until 
objective PD or death” in Table 3 to clarify censoring rules.
Added clarification to following sections:
Section 6.5.1. Demographics
Section 6.5.2. Baseline Disease Characteristics
Section 6.6 Breast Cancer History
Section 6.7. Non-breast Cancer History
Section 6.9. Prior Cancer Surgeries and Procedures
Section 6.10 Prior Anti-cancer Therapy
Section 6.11 Prior Radiation Therapy
Section 7.3. Subgroup Analysis
9.2 Adverse Events
9.3. Adverse Events of Special Interest
Section 11. Changes to Analysis Specified in Protocol: Update age 
categories to align with previous Sacituzumab Govitecan studies.
4.0
24Aug2021

Section 2.2 Secondary Objectives and Section 2.3 
 
Objectives updated to align with Protocol Amendment 7.

Section 3.2 Determination of Sample Size updated to align with 
Protocol Amendment 7 adding clarification on removal of interim 
analysis of ORR in Protocol Amendment 6.

Section 3.3 Interim Analysis updated to align with protocol 
clarifying removal of interim analysis of ORR in Protocol 
Amendment 6 and adding two interim analyses for OS. 
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IMMU-132-09 Statistical Analysis Plan 
Version Numbe1· 
Version Date 
5.0 
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CONFIDENTIAL 
Final 
Summa1-y and Rational ofRevision(s) 
• 
Section 3.4 Multiplicity Adjustment updated to align with protocol 
detailing alpha allocation for OS. Hierarchical testing added to align 
with Protocol Amendment 7. 
• 
Section 4 Study Endpoints updated to align with Protocol 
Amendment 7 
• 
Section 5 Analysis Population updated to remove Per-protocol 
population and Response Evaluable population; changed the 
Enrolled population to Screened population to be consistent with 
ASCENT study; add HRQoL-evaluable population for HRQoL 
related analysis; add PK population for PK related analysis. 
• 
Section 7.2.4.1 EQRTC-QLQ-C30 updated to remove QLQ-C30 
Summary Score, remove MMRM analysis and add Time to 
deterioration analysis to align with Protocol Amendment 7. 
• 
Section 7.2.4.2 updated to remove scoring and MMRM analysis 
• 
Section 7.4.1 Remove PFS2 analysis since no much reliable data are 
collected after the I st PD . 
• 
• 
• 
Section IO Add the detailed description of missing data handling 
• 
Section 11 No change to the analysis specified in Protocol 
Amendment7 
• 
Section 3 Updated the analysis plan to combine the prima1y PFS 
(final) analysis and OS first interim analysis. Rationale: As of 
03Jan22, the targeted number of events required for the first interim 
OS analysis has been reached. At this time 329 PFS events for the 
final PFS analysis have been reached (actual number of events is 
subject to change due to ongoing data cleaning activities). 
Conducting the final PFS analysis with >90% of the 350 PFS events 
has negligible impact on the overall study power. 
• 
Section 5 Added EQ-5D-5L Evaluable Population for analyses of 
EQ-5D-5L endpoints since the specified population 
(HRQoL-Evaluable Population) in the previous version of SAP is 
not applicable; updated population for endpoints related to antidrug 
antibody (ADA) as Immunogenicity Analysis Population; updated 
definition of PK population to align with Gilead convention; 
analyses population ofEORTC endpoints other than time to 
deterioration clarified. 
• 
Section 7. I Updated censoring mle for prima1y PFS analysis to align 
with industry convention, which is due to an oversight in previous 
versions of SAP to 1niss the case of death occurs after the initiation 
of other anti-cancer therapy for censoring; Sensitivity analyses 2 
updated to align with FDA guideline: earliest date of treatment 
discontinuation or initiation of new anti-cancer therapy is considered 
as progression event; Sensitivity analyses 4 for primary PFS analysis 
added to ali 
with EMA 
ideline; Table 3 describin censorin 
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Version Number
Version Date
Summary and Rational of Revision(s)
rules of primary and sensitivity analyses of PFS is also updated to 
align with all the changes.

Section 7.2.2 Removed BOR concordance analyses between LIR and 
BICR given ORR is no longer primary endpoint since Protocol 
Amendment 6.

Section 7.2.3 Updated censoring rule of DOR to align with the 
censoring rules of primary PFS analysis.

Section 7.2.5 Updated definition of time to deterioration (TTD) 
endpoints to include death as event to align with the approach in 
ASCENT trial; added sensitivity analysis without using death as 
events; clarified the analysis set of TTD further to include subjects 
with baseline value at risk only.

Section 8 Updated PK analyses to clarify the PK concentration and 
parameters to be summarized.

Section 9.3 Removed summary of reasons for dose reduction since it 
is covered in the summary of AE leading to dose reduction; Updated 
definition of AESI of Hypersensitivity+ to include not only infused 
treatments but also oral capecitabine.

Other minor updates for clarification or correction.


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TABLE OF CONTENTS
STATISTICAL ANALYSIS PLAN ...............................................................................................................................1
APPROVAL SIGNATURE PAGE ................................................................................................................................2
REVISION HISTORY....................................................................................................................................................3
TABLE OF CONTENTS................................................................................................................................................6
LIST OF IN-TEXT TABLES .........................................................................................................................................7
LIST OF IN-TEXT FIGURES........................................................................................................................................7
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ...................................................................................8
1.
INTRODUCTION................................................................................................................................................10
2.
STUDY OBJECTIVES ........................................................................................................................................11
2.1.
Primary Objective....................................................................................................................................11
2.2.
Secondary Objectives ..............................................................................................................................11
3.
STUDY OVERVIEW ..........................................................................................................................................13
3.1.
Study Design ...........................................................................................................................................13
3.2.
Determination of Sample Size.................................................................................................................14
3.3.
Interim Analysis ......................................................................................................................................14
3.4.
Multiplicity Adjustment ..........................................................................................................................15
4.
STUDY ENDPOINTS..........................................................................................................................................17
4.1.
Primary Efficacy Endpoints ....................................................................................................................17
4.2.
Secondary Efficacy Endpoints ................................................................................................................17
4.3.
Safety Endpoints......................................................................................................................................17
5.
ANALYSIS POPULATIONS..............................................................................................................................19
6.
STATISTICAL METHODS AND ANALYSIS..................................................................................................22
6.1.
General Statistical Considerations...........................................................................................................22
6.2.
Patient Accrual and Eligibility ................................................................................................................22
6.3.
Subject Disposition..................................................................................................................................22
6.4.
Important Protocol Deviations ................................................................................................................23
6.5.
Demographics and Baseline Disease Characteristics..............................................................................23
6.5.1.
Demographics........................................................................................................................23
6.5.2.
Baseline Disease Characteristics ...........................................................................................23
6.6.
Breast Cancer History..............................................................................................................................23
6.7.
Non-breast Cancer History......................................................................................................................23
6.8.
Non-protocol Specific Procedures...........................................................................................................24
6.9.
Prior Cancer Surgeries and Procedures ...................................................................................................24
6.10.
Prior Anti-cancer Therapy.......................................................................................................................24
6.11.
Prior Radiation Therapy ..........................................................................................................................24
6.12.
Prior, Concomitant Medications and Medical History Excluding Cancer..............................................24
6.12.1.
Prior and Concomitant Medications......................................................................................24
6.12.2.
Medical History Excluding Cancer .......................................................................................25
7.
EFFICACY ANALYSES.....................................................................................................................................26
7.1.
Analysis of Primary Efficacy Endpoints .................................................................................................26
7.1.1.
Progression-Free Survival (PFS) per BICR ..........................................................................26
7.2.
Analysis of Secondary Efficacy Endpoints .............................................................................................30
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IMMU-132-09 Statistical Analysis Plan 
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7.3. 
7.5. 
7.2.1. 
7.2.2. 
7.2.3. 
7.2.4. 
7.2.5. 
Overall Survival (OS) ............................................................................................................ 30 
Objective Response Rate (ORR) and Clinical Benefit Rate (CBR) ...................................... 30 
Duration of Response (DOR) ................................................................................................ 31 
Progression-Free Swvival (PFS) per LIR ............................................................................. 31 
Patient Rep01ted Outcomes (EORTC QLQ-C30) ................................................................. 32 
Anal ses .................................................................................................................................. 34 
8. 
PHARMA CO KINETIC AND BIO MARKER ANALYSES ............................................................................... 36 
8.1. 
Pha1macokinetic Analyses ....................................................................................................................... 36 
8.2. 
Biomarker Analyses ................................................................................................................................ 36 
8.3. 
Immunogenicity (Anti-Dmg Antibodies) Analysis ................................................................................. 36 
9. 
SAFETY ANALYSES ......................................................................................................................................... 37 
9.1. 
Exposure to Study D1ug and Compliance ............................................................................................... 37 
9.2. 
Adverse Events ........................................................................................................................................ 38 
9.3. 
Adverse Events of Special Interest (AESI) ............................................................................................. 39 
9.4. 
Dea.th ....................................................................................................................................................... .40 
9.5. 
Clinical La.boratoiy ................................................................................................................................. .40 
9.6. 
Vital Signs .............................................................................................................................................. .41 
9. 7. 
Electrocardiogra.1ns ................................................................................................................................. .41 
9.8. 
ECOG perfonnance status ...................................................................................................................... .42 
9.9. 
Physical Examination and Pregnancy Test. ............................................................................................ .42 
10. METHODS FOR HANDLING MISSING DATA ............................................................................................. .43 
11. CHANGES TO ANALYSIS SPECIFIED IN PROTOCOL ............................................................................... .45 
12. REFERENCES .................................................................................................................................................... .46 
Table 1. 
Table 2. 
Table 3. 
Table 4. 
Table 5. 
Table 6. 
Figure 1. 
CONFIDENTIAL 
LIST OF IN-TEXT TABLES 
Overall Statistical Inference .................................................................................................... 16 
An Ove1view of Analyses and Analysis Populations .............................................................. 20 
Censoring Rules for the Endpoint of PFS ............................................................................... 28 
Censoring Rules for the Endpoint of DOR .............................................................................. 31 
Scoring the EORTC QLQ-C30 ................................................................................................ 33 
Definitions of Adverse Events of Special Interest. ................................................................. .40 
LIST OF IN-TEXT FIGURES 
Hierarchical Testing Procedw·es .............................................................................................. 16 
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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
ADA
Anti-drug antibody
ADaM
Analysis Data Model
AE
Adverse event
AEOSI
Adverse event of special interest
ALT
Alanine aminotransferase
AST
Aspartate aminotransferase
ATC
Anatomical Therapeutic Chemical
BICR
Blinded independent central review
BMI
Body mass index
BOR
Best overall response
BUN
Blood urea nitrogen
C1D1
Cycle 1 Day 1
CBR
Clinical benefit rate
CDK
Cyclin-dependent kinases
CI
Confidence interval
CR
Complete response
CRF
Case report form
CT
Computed tomography imaging
CTCAE
Common Terminology Criteria for Adverse Events
DOR
Duration of response
DSMC
Data Safety Monitoring Committee
ECG
Electrocardiogram
ECOG
Eastern Cooperative Oncology Group
EORTC QLQ
European Organization for the Research and Treatment of Cancer Quality of Life 
Questionnaire 
EOT
End of treatment
FDA
Food and Drug Administration
HER2-
Human Epidermal Growth Factor Receptor 2 Negative
HR+
Hormonal receptor positive
HR-QOL
Health-Related Quality of Life
IND
Investigational New Drug Application
ITT
Intent to treat
KM
Kaplan Meier
LDH
Lactate dehydrogenase
LIR
Local Investigator Review
MBC
Metastatic Breast Cancer
MedDRA
Medical Dictionary for Regulatory Activities
NCI
National Cancer Institute
NE
Not Evaluable


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ORR
Objective response rate
OS
Overall survival
PD
Progressive disease
PFS
Progression-free survival
PK
Pharmacokinetics
PR
Partial response
PRO
Patient reported outcomes
PT
Preferred term
QoL
Quality of life
RECIST
Response Evaluation Criteria in Solid Tumors (version 1.1)
SAE
Serious adverse event
SAP
Statistical analysis plan
SD
Stable disease
SG
Sacituzumab govitecan
SMQ
Standard MedDRA Query
SOC
System organ class
TEAE
Treatment-emergent adverse event
TPC
Therapy of physician’s choice
TTD
Time to deterioration 
WHO
World Health Organization


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1.
INTRODUCTION
The purpose of this Statistical Analysis Plan (SAP) is to describe the procedures and the 
statistical methods that will be used to analyze, and report results for study IMMU-132-09: 
“Phase 3 Study of Sacituzumab Govitecan (IMMU-132) versus Treatment of Physician’s Choice 
(TPC) in Subjects with Hormonal Receptor Positive (HR+) and Human Epidermal Growth 
Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (MBC) Who Have Failed at least 
Two Prior Chemotherapy Regimens”. This SAP incorporates Amendment 7 of the protocol, 
dated as 23 August 2021. The focus of this SAP is for the planned interim analysis and the final 
analysis specified in the study protocol.
This SAP provides a comprehensive and detailed description of the objectives, definitions of 
endpoints, statistical and analytical methods used to evaluate the specified efficacy and safety 
endpoints.


sacituzumab govitecan 
IMMU-132-09 Statistical Analysis Plan 
2_ 
STUDY OBJECTIVES 
2.1. 
Primary Objective 
The prima1y objective of the study is: 
Final 
• 
To assess and compare the efficacy of sacituzumab govitecan to TPC as measured by PFS as 
determined by blinded independent central review (BICR) using RECIST 1.1 {Eisenhauer 
2009} in subjects with HR+/HER2- MBC who have progressed after CDK 4/6 inhibitor, 
endocrine therapy, taxane, and at least 2, but no more than 4 prior chemotherapy regimens 
for metastatic disease 
2.2. 
Secondary Objectives 
The secondaiy objectives of the study ai·e: 
• 
To assess and compai·e sacituzumab govitecan to TPC in overall smvival (OS) in subjects 
with HR+/HER2- MBC who have progressed after CDK 4/6 inhibitor, endocrine therapy, 
taxane and at least 2, but no more than 4 prior chemotherapy treatment regimens for 
metastatic disease 
• 
To assess and compai·e ORR, DOR, and CBR between treatment aiIDS as detennined by local 
investigator review (LIR) and BICR using RECIST 1.1 
• 
To assess and compai·e the impact of treatment on time to deterioration (TTD) of global 
health status/QOL, pain, and fatigue domains as measured by European Organization for the 
Reseai·ch and Treatment of Cancer (EORTC) quality of life questionnaire version 3.0 
(QLQ-C30) 
• 
To assess and compai·e the overall safety and tolerability 
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3.
STUDY OVERVIEW
3.1.
Study Design
Study IMMU-132-09 (TROPiCS-02 [Trop-2 Investigation in Cancer with sacituzumab 
govitecan]) is an open-label, randomized, multicenter, international Phase 3 study to compare the 
efficacy and safety of sacituzumab govitecan versus TPC in subjects with metastatic or locally 
recurrent inoperable HR+/HER2- MBC who have progressed after CDK 4/6 inhibitor, endocrine 
therapy, taxane, and at least 2, but no more than 4 prior chemotherapy treatment regimens for 
metastatic disease. 
Approximately 520 eligible subjects will be randomized in a 1:1 ratio to either sacituzumab 
govitecan (Investigational Arm A) or TPC (Control Arm B; i.e., eribulin, capecitabine, 
gemcitabine, or vinorelbine). Randomization will be stratified based on prior chemotherapy 
regimens for treatment of metastatic disease (two vs. three/four lines), visceral metastasis (Y/N), 
and endocrine therapy in the metastatic setting for at least 6 months (Y/N).
The study will be conducted in two phases, a Pre-randomization Phase and a Randomization 
Phase:

The Pre-randomization Phase will last no longer than 28 days and consists of the following 
two periods:
A Screening Period to establish study eligibility
A Baseline Period to confirm eligibility and establish disease characteristics prior to 
randomization and treatment

The Randomization Phase will begin at the time of randomization of the first subject and will 
end on the data cut-off date for the final analysis of OS; the Randomization Phase consists of 
the following two periods:
A Treatment Period which begins at the time of randomization and ends with the 
completion of the End-of-Treatment (EOT) visit, which will occur at least 30 days after 
the final dose of study treatment 
A Follow-up Period which begins the day after the EOT visit and continues as long as the 
subject is alive or until the data cut-off date of the final analysis of OS, unless the subject 
withdraws consent from the study or the Sponsor terminates the study
An independent Data Safety Monitoring Committee (DSMC) will be convened at regular 
intervals to assess the progress of this study and review safety per an approved DSMC charter.


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3.2.
Determination of Sample Size
At the time of Protocol Amendment 6, the Sponsor decided to remove the interim analysis of 
ORR. Thus, the alpha originally allocated to ORR will be reverted back to the primary endpoint 
of PFS which will be tested at two-sided alpha of 0.05. In addition, two interim analyses of OS 
were added to accommodate the time gap between PFS final analysis and OS final analysis in 
Protocol Amendment 7. 
The sample size is estimated based on the primary endpoint of PFS, but also takes into account 
OS as the main secondary endpoint. An overall sample size of approximately 520 subjects will 
be randomized in a 1:1 ratio to either sacituzumab govitecan or TPC. 
For PFS, assuming a hazard ratio of 0.70 (medians of 5.3 months for sacituzumab govitecan and 
3.7 months for TPC), a total of 350 PFS events are needed to detect a statistically significant 
difference at a 2-sided alpha of 0.05 with 92% power. With an estimated average accrual rate of 
22 subjects per month, a total of 520 subjects will provide approximately 350 PFS events around 
27 months after the first subject is randomized, after accounting for events being censored 
because of subjects missing tumor assessments or starting subsequent anticancer therapies. The 
recruitment rate is assumed to be non-uniform so that half of the subjects are recruited 55% of 
the way through the recruitment period of approximately 24 months, reflecting the change in 
sample size and actual recruitment rate that was affected by the global COVID-19 pandemic. For 
OS, assuming a hazard ratio of 0.73 (medians of 16.5 months in Arm A and 12 months in Arm 
B), a total of 438 OS events are needed to detect a statistically significant difference 86.7% 
power at a 2-sided alpha of 0.05, based on a recruitment period of 24 months and 52 months of 
survival follow up from the first subject randomized.
The Sponsor will closely monitor the number of subjects randomized and discontinued, 
including subjects who refuse study treatment assigned. As the primary analysis is triggered by a 
targeted number of PFS events, subjects who prematurely discontinue from the study or whose 
events are censored do not count toward the targeted number. To compensate for such cases, an 
additional number of subjects may be necessary to be enrolled to ensure the targeted number of 
events is reached within a reasonable timeframe. If required, the additional number of subjects 
will be determined by the Sponsor on the basis of the number and pattern of accumulated and 
censored events at the appropriate times as the study progresses. Additionally, the projected time 
to reach analysis milestones and the duration of subjects’ follow-up may be different from what 
are estimated due to differences of actual enrollment rates from the assumptions and the impact 
of COVID-19 pandemic.
3.3.
Interim Analysis
The study is planned to have 2 superiority interim efficacy analyses of the secondary endpoint, 
OS, performed when approximately a total of 272 (62% information fraction) and 350 (80% 
information fraction) death events have occurred, respectively. The method used to account for 
the multiplicity introduced by efficacy interim analyses is described in Section 3.4.
There is no planned interim analysis of PFS in this study.


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As of 03Jan22, the targeted number of events required for the first interim OS analysis has been 
reached. At this time, 329 PFS events for the final PFS analysis have been reached (actual 
number of events is subject to change due to ongoing data cleaning activities). Conducting the 
final PFS analysis with >90% of the 350 PFS events has negligible impact on the overall study 
power (e.g., >90% power if the actual observed event number is 329). Therefore, the Sponsor 
plans to conduct the final (and only) analysis for PFS and the first interim superiority analysis for 
OS together. The prespecified PFS and OS analyses will be provided in a combined data 
package.
3.4.
Multiplicity Adjustment
The overall type I error rate for this study is strictly controlled at a 2-sided alpha of 0.05. The 
primary endpoint analysis of PFS assessed by BICR will serve as the gatekeeper for the 
secondary endpoint analyses and be tested at the 2-sided alpha of 0.05. If the primary PFS 
analysis is positive, analysis of the main secondary endpoints of OS will be formally tested 
sequentially at the 2-sided alpha of 0.05, ORR (assessed by BICR) and analysis for QOL will be 
formally tested sequentially at the 2-sided alpha of 0.05 respectively when the above hypotheses 
in the hierarchy are also statistically significant. For analysis of QOL, time to deterioration 
(TTD) of global health status/QoL, pain, and fatigue domains as measured by EORTC QLQ-C30 
will be tested using the graphical approach of Maurer and Bretz to control multiplicity {Maurer 
2013}. According to this approach, the hypotheses may be tested more than once, and when a 
particular null hypothesis is rejected, the alpha allocated to that hypothesis can be reallocated to 
other hypothesis tests. The arrows on the diagram show how the Type I error allocated to a null 
hypothesis that is successfully rejected will be redistributed for the testing of the other 
hypotheses. Please note that the arrows do not necessarily indicate the testing order. A 
Bonferroni approach is used to control the Type I error rate at 0.05 (2-sided) alpha for 3 TTD 
hypothesis tests (see Figure 1).
The Lan DeMets alpha spending function that approximates a Pocock approach {Lan 1983} will 
be used to account for multiplicity introduced by including OS interim analyses for superiority. 
The first OS efficacy interim analysis will be tested at the 2-sided significance level of 0.0363 if 
62% of the death events (272/438) is available at the time of the analysis. If the first OS interim 
analysis is not positive, the second OS efficacy interim analysis will be tested at the 2-sided 
significance level of 0.0207 if 80% of death events (350/438) is available at the time of the 
analysis. If neither of interim analyses is positive, final analysis will be tested at the 2-sided 
significance level of 0.0196. Note that alpha levels for the OS interim and final analyses are 
based on the actual observed events and will be adjusted accordingly.
Statistical inferences in terms of nominal alpha-value for planned analyses are summarized in 
Table 1.


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Table 1.
Overall Statistical Inference
Description
Clinical cutoff
2-sided significance level
Primary PFS analysis 
(Final)
Approximately 350 primary 
endpoint PFS events†
0.05
OS 1st interim analysis
272 deaths
0.0363*
OS 2nd interim analysis
350 deaths
0.0207*
OS analysis (Final)
438 deaths
0.0196*
†
Actual number of primary PFS events within +/- 10% of target 350 events is acceptable for the primary PFS analyses (final). 
Full alpha will be used at the final (and only) analysis for primary endpoint PFS.
*
The boundary p-values at each analysis timepoint will be based on the actual observed events and adjusted by using the Lan 
DeMets alpha spending function that approximates a Pocock approach.
Figure 1.
Hierarchical Testing Procedures
PFS assessed by BJCR in ITT 
2-sided a.= 0.05 
Yes 
ORR assessed by BICR In ITT 
2-slded a= 0.05 
Time to deterioration of 
global health status/Qol 
as measured by EORTC 
QLQ-C30 
2-sided 1/3 a 
l 
Yes 
0.5 
0.5 
Time to deterioration 
of pain as measured 
by EORTC QLQ-O0 
2-sided 1/3 a 
No 
Time to deterioration 
of fatigue as 
mea5ured by EORTC 
QLQ-C30 
2-sided 1/3 a 
Stop 
Stop 
top 


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4.
STUDY ENDPOINTS
4.1.
Primary Efficacy Endpoints

PFS as determined by BICR using RECIST 1.1
4.2.
Secondary Efficacy Endpoints

OS 

ORR as determined by BICR using RECIST 1.1

TTD in global health status/QoL, pain and fatigue domain of EORTC QLQ-C30 

ORR as determined by LIR using RECIST 1.1

DOR as determined by BICR and LIR using RECIST 1.1

CBR as determined by BICR and LIR using RECIST 1.1

PFS as determined by LIR using RECIST 1.1
4.3.
Safety Endpoints

Incidence of AEs and SAEs

Clinical laboratory data (i.e. Hematology, Chemistry, Urinalysis)

ECG

ECOG performance status

Vital signs (i.e. heart rate, systolic and diastolic blood pressure, respiratory rate, temperature)
The correlation between ADA and Safety will be addressed in Sections 4.4 and 8.3 and a 
separate analysis plan.


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CCI


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5.
ANALYSIS POPULATIONS
The following analysis populations will be used for analyses: 

Screened Population: defined as all subjects who have signed an informed consent and 
participated in screening procedures at the investigative site to assess eligibility. This 
analysis population is used for selected tables and listings pertaining to subjects’ disposition 
and eligibility criteria.

Intent-to-Treat (ITT) Population/Full Analysis Set: defined as all subjects who are 
randomized, regardless of whether they received study treatment or not.  The efficacy 
analysis will be performed on the ITT population. Subjects will be analyzed according to the 
randomized treatment.

Safety Population: defined as all ITT subjects who have received at least one dose of study 
drug.  This is the analysis population for all safety analyses which will be based on the actual 
treatment received.

HRQoL-Evaluable Population: defined as ITT population subjects who have an evaluable 
assessment of the HRQoL at baseline and at least one evaluable assessment at post-baseline 
visits. An evaluable assessment at a given visit will be defined as at least one of the 15 
domains/scales were non-missing at that scheduled assessment visit.

EQ-5D-5L Evaluable Population: defined as ITT population subjects who have an evaluable 
assessment of the EQ-5D-5L at baseline and at least one evaluable assessment at 
post-baseline visits. An evaluable assessment at a given visit will be defined as at least one of 
the 5 dimensions or VAS score were non-missing at that scheduled assessment visit.

PK Population: defined as Safety population subjects who had at least one dose of 
sacituzumab govitecan treatment and have at least one non-missing PK concentration of SG, 
total SN-38, free SN-38, or total antibody (hRS7 IgG).

Immunogenicity Analysis Population: defined as Safety population subjects who had at least 
one dose of sacituzumab govitecan treatment and at least one blood sample for 
immunogenicity evaluation after sacituzumab govitecan administration.

Analysis populations used for biomarker analyses will be defined in a separate analysis plan 
and not subject to the scope of this SAP.
An overview of the analyses and their analyses population are provided in Table 2. 


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Table 2.
An Overview of Analyses and Analysis Populations
Analysis 
Category
Screened 
Population
Intent-to-Treat 
(ITT) 
Population
HRQoL/EQ-5D-5L 
Evaluable 
Populations 
Safety 
Population
PK/Immunogenicity 
Analysis 
Populations
Enrollment and 
Eligibility 
X
Demographics 
X
X
Baseline Disease 
Characteristics
X
Patient 
Disposition
X
Breast and non-
breast Cancer 
History
X
Protocol 
Deviation
X
Prior Anticancer 
Therapy, Prior 
Cancer 
Surgeries, Prior 
Radiation 
Therapy, Prior 
and Concomitant 
Medications, 
Medical History
X
Exposure to 
Study Therapies
X
Efficacy on 
primary endpoint 
(BICR assessed 
PFS)
X
Secondary 
Efficacy 
endpoint (LIR 
assessed PFS)
X
Secondary 
Efficacy 
endpoint ORR 
(BICR assessed)
X
Secondary 
Efficacy 
endpoint ORR 
(LIR assessed)
X
Secondary 
Efficacy 
endpoints (CBR, 
DOR, BICR and 
LIR assessed)
X


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Analysis 
Category
Screened 
Population
Intent-to-Treat 
(ITT) 
Population
HRQoL/EQ-5D-5L 
Evaluable 
Populations 
Safety 
Population
PK/Immunogenicity 
Analysis 
Populations
Secondary 
Efficacy 
endpoints (OS, 
TTD in global 
health 
status/QoL, pain 
and fatigue)
X (OS)
X (Only TTD in 
global health 
status/QoL, pain 
and fatigue)
Efficacy 
Subgroup 
Analyses
X
Safety Analyses
(AE, AESI, 
ECG, ECOG 
performance 
status, Vital 
Sign, Clinical 
Lab, Physical 
Exam and 
Pregnancy Test)
X
Death
X
PK analyses 
(Cmax, Tmax, and 
Ctrough)
X (PK Population)
Immunogenicity 
(Anti-drug 
antibody)
X (Immunogenicity 
Analysis Population)
CCI
CCI


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6.
STATISTICAL METHODS AND ANALYSIS
6.1.
General Statistical Considerations
Endpoints and analyses pertaining to the study’s primary, secondary and exploratory objectives 
will be conducted as prescribed in respective sections of this SAP. Any notable analyses, 
adjustments to analyses, or analyses not conducted due to lack of data (such as insufficient 
numbers of subjects in subgroups) or due to other technical constraints will be noted, if included 
in the clinical study report. 
All efficacy analyses will be analyzed in the ITT population and all safety analyses will be 
analyzed in the safety population.
Continuous data will be summarized using descriptive statistics: n (number of subjects), mean, 
median, standard deviation, and range (minimum and maximum), unless otherwise specified. 
Categorical data will be summarized using counts and percentages. For summary statistics, the 
tables will be presented by treatment arm, and when warranted, may include an overall column. 
In general, individual subject listings will be provided to support the tables.
All calculations and analyses will be conducted using SAS version 9.2 or higher. 
6.2.
Patient Accrual and Eligibility
Number and percentage of subjects screened and randomized will be summarized and listed for 
the Screened Population. 
Screen failures will be summarized for the Screened Population by the screen failure reasons as 
collected per CRF.
A by-subject listing will be provided for the screened population, including their Informed 
Consent dates, Protocol Amendment Number the subject is consented under, whether the subject 
is a screen failure, the primary reason for screen failure, and whether the subject is included in 
each of the analysis populations. Subjects who are randomized but never received treatment will 
be presented with the reason for not being treated, if known.
6.3.
Subject Disposition
The numbers and percentages of subjects randomized, ongoing treatment, ongoing study, 
permanently discontinued from treatment and discontinued from study, and reasons for treatment 
or study discontinuation will be summarized for the ITT population.  The numbers and 
percentages of subjects included in each analysis population will also be summarized by 
treatment arm. The percentage will be calculated relative to the number of subjects randomized.
By-subject listing will be provided to include the following: treatment status, treatment start/end 
date, reason for treatment discontinuation, study completion status, study end date and reason for 
study discontinuation.


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6.4.
Important Protocol Deviations
Important protocol deviation criteria are established and subjects with important protocol 
deviations will be identified and documented. Important protocol deviations will be summarized 
for the ITT population if warranted. Important protocol deviations will also be listed by subject.
6.5.
Demographics and Baseline Disease Characteristics
Demographics for the ITT and safety populations will be summarized using descriptive statistics. 
Baseline Disease Characteristics will be summarized for the ITT population.
Individual subject listings will be provided to support the summary tables.
6.5.1.
Demographics
Baseline demographic data summaries will include age (years), age by categories (< 65 or 
≥ 65 years), sex, race, ethnicity.
6.5.2.
Baseline Disease Characteristics 
Baseline disease characteristics will include but are not limited to: stratification factors of prior 
chemotherapy regimens for treatment of metastatic disease (two versus three/four lines), visceral 
metastasis (Yes/No), and endocrine therapy in the metastatic setting for at least 6 months 
(Yes/No), ECOG at screening, UGT1A1 status. 
By-subject listing will be generated according to information as collected from CRFs per each 
treatment arm.
6.6.
Breast Cancer History 
Breast cancer history will include: time from confirmed metastatic disease to randomization, 
current breast cancer tumor stage, current breast cancer node stage, current breast cancer 
metastasis stage, HER2 status, IHC/FISH results, estrogen receptor status, progesterone receptor 
status, BRCA1 mutation status, and BRCA2 mutation status.  Breast cancer history will be 
summarized for the ITT population.
By-subject listing will be generated according to information as collected from CRFs per each 
treatment arm.
6.7.
Non-breast Cancer History
Non-breast cancer history will include: time from initial diagnosis to randomization, cancer site, 
staging at initial diagnosis, histological type, disease classification, time from confirmed 
metastatic disease to randomization date and site of known metastases.  Non-breast cancer 
history will be summarized for the ITT population. 
By-subject listing will be generated according to information as collected from CRFs per each 
treatment arm.


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6.8.
Non-protocol Specific Procedures
By-subject listing will be generated according to information as collected from CRFs per each 
treatment arm.
6.9.
Prior Cancer Surgeries and Procedures
By-subject listing will be generated for all prior cancer surgeries and procedures according to 
information as collected from CRFs. 
6.10.
Prior Anti-cancer Therapy
Prior anti-cancer therapy will include the following: number of subjects with different regimens, 
reason for administration (neoadjuvant, adjuvant, advanced/metastatic, unknown and other), best 
response for the last therapy before entering study and time from last disease progression to 
randomization date.
Prior anti-cancer therapy will be coded using the World Health Organization (WHO) Drug 
Dictionary and summarized by Preferred Drug Name for ITT population.  
By-subject listing will be generated according to information as collected from CRFs.
6.11.
Prior Radiation Therapy
Prior radiation therapy will include anatomical site, duration of therapy, time from last therapy to 
randomization date, and best response in the last therapy before study. The last therapy refers to 
the therapy whose end date is the last before randomization date.
By-subject listing will be generated according to information as collected from CRFs.
6.12.
Prior, Concomitant Medications and Medical History Excluding Cancer
6.12.1.
Prior and Concomitant Medications
Prior and concomitant medications will be coded using the World Health Organization (WHO) 
Drug Dictionary. Prior medications include medication with a start and end date prior to first 
administration of study drug. Concomitant medications are those medications that were taken at 
any time while on study treatment, including medication that were started before first dose of 
study therapy but were ongoing at the time of first dose of study drug or that were initiated after 
first dose but prior to 30 days after last dose. If an end date is missing or the medication is 
ongoing during study treatment, the medication will be included as concomitant medications. 
Prior and concomitant medications will be summarized separately for the ITT population by 
following the WHO Drug Anatomical Therapeutic Chemical (ATC) Classification, and listed for 
the ITT population.


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6.12.2.
Medical History Excluding Cancer
Medical history excluding cancer will be summarized for the ITT population and listed by 
subject for each treatment arm. Medical history will be summarized by system organ class (SOC) 
and preferred term (PT) and sorted by frequency in SOC and by decreasing frequency in PT.


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7.
EFFICACY ANALYSES
Efficacy analyses will be performed on the ITT population.  
7.1.
Analysis of Primary Efficacy Endpoints
7.1.1.
Progression-Free Survival (PFS) per BICR
PFS is defined as the time from date of randomization to the first observation of documented 
disease progression based on RECISIT 1.1 or death due to any cause, whichever comes first. 
Primary analysis of PFS will be based on BICR for ITT population.
The following censoring rules will be applied to the primary analysis of PFS: 
A) A patient who dies during follow-up period for survival without documented progressive 
disease will be considered to have an event for PFS analysis.
B) Patients who do not have progression and are alive will be censored at last date of 
radiographic assessment without documented progressive disease.
C) Patients that progress or die following more than one missed scheduled visit of scheduled 
assessment interval, as defined in the protocol, will be censored at the last date of 
radiographic assessment without documented progressive disease prior to the missed 
assessment.
D) Patients who receive alternative anticancer treatment before documented progressive disease 
or death will be censored at the last date of radiographic assessment without documented 
progressive disease prior to receiving alternative anticancer treatment. 
E) Patients without baseline tumor assessments or without additional follow-up data will be 
censored at the date of randomization. However, if these patients die without initiation of 
alternative anti-cancer treatment and no later than the time of the second scheduled 
assessment as defined in the protocol, these patients will be considered to have an event at 
the date of death. 
In order to evaluate the robustness of the primary PFS analysis, several sensitivity analyses will 
be performed using the following modified definitions of PFS:

Sensitivity Analysis 1 of PFS will use the same censoring rule of the primary PFS definition 
except that any subject who progresses or dies after more than one missed scheduled tumor 
assessment will not be censored at the last date of radiographic tumor assessment prior to the 
missed assessment.


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
Sensitivity Analysis 2 of PFS will use the same censoring rule of the primary PFS definition 
except that it considers discontinuation of treatment or initiation of alternative anticancer 
treatment, whichever occurs earlier, to be a PD event.

Sensitivity Analysis 3 of PFS will use the same primary PFS definition and censoring rules, 
but for all treated subjects who received at least one dose of study drug.

Sensitivity Analysis 4 of PFS will use the same censoring rule of the primary PFS definition 
except that any subject who initiates other anti-cancer treatment prior to disease progression 
or death or who progresses or dies after more than one missed scheduled tumor assessment 
will not be censored.
Calculation and censoring rules of PFS are described in Table 3. 


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Table 3.
Censoring Rules for the Endpoint of PFS
Date of Event/Censoring1
Case
Outcome
Primary Analysis
Sensitivity analysis 1
Sensitivity analysis 2
Sensitivity analysis 4
No adequate response assessment after randomization
No baseline tumor 
assessment or alive
Censored
Randomization date
Randomization date
Randomization date
Randomization date
Died prior to second 
scheduled assessment 
without initiation of 
other anti-cancer therapy
Death
Date of death
Date of death
Date of death
Date of death
Died after missing 2 or 
more scheduled 
successive assessments 
Primary analysis and 
Sensitivity analysis 2:
Censored
Sensitivity analysis 1 and 4:
Death
Randomization date
Date of death 
Randomization date
Date of death
Continued scheduled response assessments until PD or death
PD prior to missing 2 or 
more scheduled 
successive assessments 
PD
Date of PD
Date of PD
Date of PD
Date of PD
Death prior to missing 
2 or more scheduled 
successive assessments
Death
Date of death
Date of death
Date of death
Date of death
PD or death after 
missing 2 or more 
scheduled successive 
assessments
Primary analysis and 
Sensitivity analysis 2: 
Censored
Sensitivity analysis 1 and 4: 
PD or death
Date of last adequate 
response assessment 
before missed ones
Date of PD or Death, 
whichever occurs first
Date of last adequate 
response assessment 
before missed ones
Date of PD or Death 
whichever occurs 
earlier
I 
I 
I 


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Date of Event/Censoring1
Case
Outcome
Primary Analysis
Sensitivity analysis 1
Sensitivity analysis 2
Sensitivity analysis 4
Treatment 
Discontinuation (for 
sensitivity analysis 2 
only) or initiated other 
anti-cancer treatment 
prior to PD or death
Primary analysis and 
Sensitivity analysis 1: 
Censored
Sensitivity analysis 2:
PD
Sensitivity analysis 4:
PD or death
Date of last adequate 
response assessment 
without documented 
progression prior to 
starting other anti-
cancer treatment
Date of last adequate 
response assessment 
without documented 
progression prior to 
starting other anti-
cancer treatment
Date of 
discontinuation of 
treatment or start date 
of anti-cancer therapy 
whichever occurs 
earlier.
Date of PD or Death 
whichever occurs 
earlier
Continued scheduled response assessments without PD or death
Treatment 
discontinuation (for 
sensitivity analysis 2 
only) or initiated other 
anti-cancer treatment
Primary analysis and 
Sensitivity analysis 1 and 4: 
Censored
Sensitivity analysis 2:
PD
Date of last adequate 
response assessment 
without documented 
progression prior to 
starting other anti-
cancer treatment
Date of last adequate 
response assessment 
without documented 
progression prior to 
starting other anti-
cancer treatment
Date of 
discontinuation of 
treatment or start date 
of anti-cancer therapy 
whichever occurs 
earlier.
Date of last adequate 
response assessment 
regardless of the 
starting of other anti-
cancer treatment
No PD or death
Censored
Date of last adequate 
response assessment
Date of last adequate 
response assessment
Date of last adequate 
response assessment
Date of last adequate 
response assessment
1.
Adequate response assessment was defined as a response assessment other than 'not assessed' or 'not evaluable'. If progression was based on the sum of target lesion 
measurements at different time points, the last measurement date was to be used as the date of progression. For progression based on new or non-target lesions considered 
unequivocal progression, the earliest date when progression was detected was to be used as the date of progression.


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The primary analysis of PFS in the ITT Population for comparison between sacituzumab 
govetican and the control TPC arm will be performed using a stratified log-rank test stratified by 
randomization factors as employed in the randomization. Estimate of hazard ratio and its 
95% confidence interval will be based on stratified Cox proportional-hazards model with 
treatment arm as the only covariate, stratified by the same stratification factors employed in the 
randomization. The test comparing the treatment groups will be performed using a 2-sided alpha 
level of 0.05. PFS will be plotted over time using Kaplan-Meier (K-M) curves, median PFS will 
be derived by Kaplan-Meier estimates and its associated 95% CIs are calculated by the 
Brookmeyer and Crowley method with log-log transformation {Brookmeyer 1982}. Milestone 
PFS rates at time points including 6 months, 9 months, and 12 months will be derived from KM 
estimates. 
7.2.
Analysis of Secondary Efficacy Endpoints
7.2.1.
Overall Survival (OS)
OS is defined as the time from randomization into study to death from any cause. Patients 
without documentation of death are censored on the date they were last known to be alive.
OS will be analyzed by the same method as the primary PFS analysis.  Analysis of OS will be 
performed on ITT population.
Milestone OS rates at time points including 12 months, 18 months and 24 months will be derived 
from the KM estimates. 
7.2.2.
Objective Response Rate (ORR) and Clinical Benefit Rate (CBR)
Objective Response Rate (ORR) is defined as the proportion of subjects who have a best overall 
response of either complete response (CR) or partial response (PR) that is confirmed ≥ 4 weeks 
later according to blinded independent clinical review (BICR) using RECIST 1.1.
Clinical Benefit Rate (CBR is defined as the proportion of subjects who have best overall 
response of CR, PR or durable SD (duration of SD ≥ 6 months after randomization).
The ORR and CBR will be analyzed and compared between the treatment arms using the 
Cochran-Mantel-Haenszel method stratified by the stratification factors used in the 
randomization. The 2-sided 95% CIs will be calculated by the Clopper-Pearson exact 
method{Clopper 1934}.  ORR and CBR will be analyzed based on both BICR and LIR 
assessments. 
Number and percentage of subjects with a best overall response of complete response (CR), 
Partial response (PR), Stable Disease (SD), Progressive Disease (PD), and Not Evaluable (NE) 
will be summarized based on LIR and BICR assessments.


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7.2.3.
Duration of Response (DOR)
For subjects experiencing response (a best overall response of CR or PR), DOR will be 
calculated based on the time between the first date showing a documented response of CR or PR 
and the date of progression or death (whichever occurs first). Subjects who do not progress or die 
after response will be censored, and the censoring rules as described in the following Table 4 
will apply.  DOR will be analyzed based on both BICR and LIR assessments.  
Table 4.
Censoring Rules for the Endpoint of DOR
Case
Outcome
Date of Event/Censoring1
Subsequent PD or death after response
PD prior to missing 2 scheduled 
successive assessments
DOR 
ended
Date of PD
Death prior to missing 2 
scheduled successive 
assessments
DOR 
ended
Date of death
PD or death after missing 2 or 
more scheduled successive 
assessments
Censor
Date of last adequate response assessment before missing ones
Initiated other anti-cancer 
treatment prior to PD or Death
Censor
Date of last adequate response assessment without documented 
progression prior to starting other anti-cancer treatment
Response without subsequent PD or death
Initiated other anti-cancer 
treatment
Censor
Date of last adequate response assessment without documented 
progression prior to starting other anti-cancer treatment
No PD or death
Censor
Date of last adequate response assessment
1 
Adequate response assessment was defined as a response assessment other than 'not assessed' or 'not evaluable'. If 
progression was based on the sum of target lesion measurements at different time points, the last measurement date was to 
be used as the date of progression. For progression based on new or non-target lesions considered unequivocal progression, 
the earliest date when progression was detected was to be used as the date of progression.
A Kaplan-Meier analysis will be performed for DOR. Median DOR will be derived by 
Kaplan-Meier estimates and 95% confidence will be calculated based on Brookmeyer and 
Crowley method with log-log transformation {Brookmeyer 1982}. The milestone DOR rate at 
3 months, 6 months, 9 months, and 12 months will be derived from the KM curve. 
7.2.4.
Progression-Free Survival (PFS) per LIR
The analysis of PFS based on LIR assessment will be conducted by using the same method as the 
primary analysis of PFS per BICR in Section 7.1.1.


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7.2.5.
Patient Reported Outcomes (EORTC QLQ-C30)
European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life of 
Cancer Patients, core questionnaire, version 3.0 (QLQ-C30), will be used to assess and compare 
the impact of treatment on Health-Related Quality of Life (HRQOL) between treatment arms.  
Subjects in the HRQoL-Evaluable Population will be included in the analysis. 
A separate prespecified QOL analysis following FDA and European Medicines Agency 
Patient-Reported Outcome Guidelines will be performed.
7.2.5.1.
EORTC QLQ-C30
EORTC QLQ-C30 Scoring
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include 
five functional scales, three symptom scales, a global health status / QoL scale, and six single 
items.
Principals for scoring these scales:
1) Derive raw score by averaging the items that contribute to the scale.
2) Standardize the raw score by applying a linear transformation so that the scores range from 0 
to 100.  A higher score presents a higher (“better”) level of functioning, or higher (“worse”) 
level of symptoms.  
Raw Score
Raw Score = RS = (I1 + I2 +…+ In)/n; where I1, I2, … In are items included in a scale
Linear transformation
Apply linear transformation to 0-100 to obtain the score S.
Functional scales:
 𝑆 =  1 ―  (𝑅𝑆― 1)
𝑟𝑎𝑛𝑔𝑒
𝑥100
Symptom scales:
 𝑆 =  (𝑅𝑆― 1)
𝑟𝑎𝑛𝑔𝑒
𝑥100
Global health status / QoL:
 𝑆 =  (𝑅𝑆― 1)
𝑟𝑎𝑛𝑔𝑒
𝑥100
Range is the difference between the maximum possible value of RS and the minimum possible 
value. The QLQ-C30 has been designed so that all items in any scale take the same range of 
values. Therefore, the range of RS equals the range of the item values.  Item numbers and item 
ranges for each scale is presented in Table 5.   
( -) 
(-) 
(-) 


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Scores for these scales will be computed only if at least half of the items contributing to the scale 
are not missing.  Otherwise the score will be set to missing.  If the response is missing for 
single-item measures, score will be set to missing.
Table 5.
Scoring the EORTC QLQ-C30
Scale
Number of 
items
Item range*
Version 3.0
Item numbers
Global health status / QoL
Global health status/QoL
QL
2
6
29, 30
Functional scales
Physical functioning
PF
5
3
1 to 5
Role functioning
RF
2
3
6, 7
Emotional functioning
EF
4
3
21 to 24
Cognitive functioning
CF
2
3
20, 25
Social functioning
SF
2
3
26, 27
Symptom scales / items
Fatigue
FA
3
3
10, 12, 18
Nausea and vomiting
NV
2
3
14, 15
Pain
PA
2
3
9, 19
Dyspnoea
DY
1
3
8
Insomnia
SL
1
3
11
Appetite loss
AP
1
3
13
Constipation
CO
1
3
16
Diarrhoea
DI
1
3
17
Financial difficulties
FI
1
3
28
*
Item range is the difference between the possible maximum and the minimum response to individual items
Absolute values and change from baseline values of EORTC QLQ-C30 functional scales, 
symptom scales and global health status QoL will be summarized descriptively.
Time to deterioration of Global health status/QoL, Pain, and Fatigue domains
Time to deterioration will be analyzed for Global health status/QoL, Pain and Fatigue domains. 
Time to deterioration is defined as the time from randomization to the first date a subject 
achieves 10-point deterioration from baseline or death due to any cause, whichever occurs first.  
Subjects who have not experienced 10-point deterioration at the time of analysis will be censored 
on the last non-missing assessment date. Subjects without baseline or post baseline PRO 
assessments will be censored at randomization date. Subject with baseline value at risk (defined 
as ≥ 10 in Global health status/QoL or ≤ 90 in Pain and Fatigue domains) will be included for 
analyses. The distribution of time to deterioration will be estimated using the Kaplan-Meier 


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method and compared between two ti·eatment groups using su-atified log-rank test. A su-atified 
Cox propo1iional-hazards model will provide estimates of hazard ratios with 95% confidence 
intervals. A sensitivity analysis without considering death as an event will also be conducted. 
7.3. 
Subgroup Analyses 
To evaluate whether the ti·eatment effect is consistent across various subgroup populations, the 
estimate of the between-group ti·eatment effect with a 95% CI for the primaiy and secondaiy 
endpoints will be estimated and plotted graphically for the following subgroups, including but 
not limited to: 
1) Sti·atification factor of number of prior chemotherapy regimens for ti·eatment of metastatic 
disease (two vs. three/four lines) 
2) Sti·atification factor of visceral metastasis (Yes/No) 
3) Sti·atification factor of endocrine therapy in the metastatic setting for ~6 months (Yes/No) 
4) Age group (<65 years old or ~65 years old) 
5) Race (white, non-white) 
6) Screening ECOG status (0 vs 1) 
7) Geographic region (No1ih America, Europe, and elsewhere) 
8) Prior CDK u-eatment duration (~12 months or > 12 months) 
9) Investigators' choice of chemotherapy (eribulin, capecitabine, gemcitabine, vinorelbine, each 
of which to compare with sacituzumab govitecan) 
10) Early relapse (Yes/No) 
( defined as relapse to metastatic disease within one year of the end of neo/adjuvant 
chemotherapy) 
11) Baseline documented Target or Non-target liver lesions per RECISTl .1 per LIR (Yes/No) 
12) Chemotherapy in neo/adjuvant setting (Yes/No) 
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8.
PHARMACOKINETIC AND BIOMARKER ANALYSES 
8.1.
Pharmacokinetic Analyses
Descriptive summary of PK concentration (SG, total SN-38, free SN-38 and total antibody - 
hRS7 IgG) and PK parameters including Cmax (maximum drug concentration), Tmax (time to 
maximum drug concentration) and Ctrough (pre-dose drug concentration) will be summarized by 
visits. A listing of PK concentrations will also be provided. Subjects in the PK population will be 
included for analyses. 
Analyses, including non-compartmental pharmacokinetics (if adequate data available) and 
population pharmacokinetics (PopPK), will be described in separate analyses plans and not in 
scope for this SAP.
8.2.
Biomarker Analyses
See Section 7.4.4 for biomarker analyses.
8.3.
Immunogenicity (Anti-Drug Antibodies) Analysis
Data on anti-drug antibody (ADA) results will be listed and may be summarized by number and 
frequency of results according to positivity of results when the prerequisite data for this analysis 
becomes available by a designated vendor. Subjects in immunogenicity analysis population will 
be included for analyses. The correlative analyses assessing the impact of ADA on PK, efficacy 
and safety endpoints will be described in separate analyses plan and not in the scope for this 
SAP.


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9.
SAFETY ANALYSES
Safety analyses will be conducted in the safety population. 
Safety data will be presented in terms of study drug exposure, AEs, clinical laboratory data, ECG 
data, and vital signs. 
9.1.
Exposure to Study Drug and Compliance
Treatment exposure will be summarized for the safety population using the following measures:

Number of doses administered

Descriptive statistics of duration of treatment (months), along with number of subjects with 
treatment duration longer than or equal to 3 months, 6 months, 12 months, and 24 months; 
Duration of treatment (in days) will be calculated as (date of the last dose - date of the first 
dose + 1) and converted to months by dividing by 30.4375

Number of treatment cycles 

Number and percentage of subjects with dose reduction according to percentage of dose 
reduction 

Descriptive statistics of time to first dose reduction.

Number and percentage of subjects with dose delays

Number and percentage of subjects with infusion interruptions

Descriptive statistics of duration of interruptions

Relative dose intensity will be calculated as described below and summarized.  Cumulative 
dosage and relative dose intensity will be summarized by descriptive statistics, and relative 
dose intensity will be additionally summarized by the category of < 70%, 70% to <90%, 90% 
to <110%, >=110%.
Delivered dose (mg) for each infusion is calculated per CRF form from (“Dose calculated for 
this subject” x “Total volume administered”/“Total volume prior to administration”). 
Delivered dosage (mg/kg) of each infusion in a cycle is calculated by dividing the delivered dose 
(in mg) by body weight (in kg) at the beginning of the cycle (the body weight according to which 
the prescribed dose is calculated and prepared per the Protocol). 
Cumulative dosage (mg/kg) received for each subject is defined as the sum of all delivered 
dosages (mg/kg) of all infusions the subject received in the study. 


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Total assigned dosage (mg/kg) for each subject is defined as the product of the assigned dose of 
sacituzumab govitecan (10 mg/kg) and number of doses the subject was scheduled to receive 
during the subject’s treatment period (number of infusions actually received by the subject plus 
the number of infusions the subject missed between the first and last infusion). 
Relative dose intensity (in %) for each subject is calculated: dividing the subject’s cumulative 
dosage received (in mg/kg) by the total assigned dosage (in mg/kg) as defined above. 
9.2.
Adverse Events
Treatment-emergent adverse events (TEAEs) are defined as any AEs that begin or worsen on or 
after the start of study drug through 30 days after the last dose of study drug. All AEs will be 
coded using Medical Dictionary for Regulatory Activities (MedDRA). The severity will be 
graded based on the National Cancer Institute’s (NCI) Common Terminology Criteria for 
Adverse Events (CTCAE) v5.0. Only TEAEs will be summarized and will be referred to as AEs 
hereafter.
The frequency and severity of AEs, classified by MedDRA, will be summarized using MedDRA 
Preferred Term (PT) and System Organ Class (SOC).  An AE that occurs more than once within 
each subject will be counted only once in the summaries, i.e., where a subject has the same 
adverse event, based on preferred terminology, reported multiple times, the subject will only be 
counted once at the preferred terminology level in adverse event summary tables. Where a 
subject has multiple adverse events within the same system organ class, the subject will be 
counted only once at the system organ class level in adverse event summary tables. When 
reporting adverse events by CTC grade, summary tables will be provided using the worst 
NCI-CTCAE grade. 
The following AE summary tables and listings will be provided:

Overall Summary of Treatment-Emergent Adverse Events

Summary of Treatment-Emergent Adverse Events by SOC and PT

Summary of Treatment-Emergent Adverse Events Reported by ≥10% Subjects in Any 
Treatment Arm by Preferred Term 

Summary of Treatment-related Treatment-Emergent Adverse Events by SOC and PT 

Summary of Treatment-Emergent Serious Adverse Events by SOC and PT 

Summary of Treatment-Emergent Serious Adverse Events Reported by ≥2% Subjects in 
Any Treatment Arm by Preferred Term

Summary of Treatment-related Treatment-Emergent Serious Adverse Events by SOC and 
PT 

Summary of Treatment-Emergent Adverse Events by Worst CTCAE Grade, SOC and PT 


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
Summary of Treatment-related Treatment-Emergent Adverse Events by Worst CTCAE 
Grade, SOC and PT

Summary of NCI-CTCAE Grade 3 or Higher Treatment-Emergent Adverse Events by 
SOC and PT

Summary of NCI-CTCAE Grade 3 or Higher Treatment-Emergent Adverse Events 
Reported by ≥5% Subjects in Any Treatment Arm by Preferred Term 

Summary of Treatment-related Treatment-Emergent Adverse Events with NCI-CTCAE 
Grade 3 or Higher by SOC and PT

Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation 
by SOC and PT

Summary of Treatment-Emergent Adverse Events Leading to Death by SOC and PT 

Summary of Treatment-Emergent Adverse Events Leading to Study Drug Interruption by 
SOC and PT

Summary of Treatment-Emergent Adverse Events Leading to Study Dose Reduction by 
SOC and PT 
The following AE listings will be provided:

Listing of All Adverse Events 

Listing of Serious Adverse Events

Listing of Adverse Events with NCI-CTCAE Grade 3 or Higher

Listing of Adverse Events Leading to Study Drug Discontinuation

Listing of Adverse Events Leading to Dose Reduction

Listing of Adverse Events Leading to Study Drug Interruption

Listing of Adverse Events Leading to Death
9.3.
Adverse Events of Special Interest (AESI)
In addition to analyses of AEs, adverse events of special interest (AESI) will be assessed. 
Definitions of AESI, as currently defined, are provided in Table 6. For AESI, frequency tables 
will include overall summary of AESI, Summary of AESI by category and PT, Serious AESI by 
category and PT, AESI leading to study drug discontinuation by category and PT, AESI leading 
to study drug interruption by category and PT, Grade 3 or higher AESI by category and PT, and 
treatment-related AESI (by a worst CTCAE grade of 3, 4, or 5, >=3 and any grade) by category 
and PT. Corresponding listings will also be produced.


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Table 6.
Definitions of Adverse Events of Special Interest
Adverse Event of Special Interest
Definition
Diarrhea
Preferred term: diarrhoea
Neutropenia+
Preferred terms: neutropenia, neutrophil count decreased, and febrile 
neutropenia
Febrile neutropenia
Preferred term: febrile neutropenia
Infections
SOC: infections and infestations
Neuropathy+
Preferred terms: gait disturbance, hypoaesthesia, muscular weakness, 
neuropathy peripheral, paraesthesia, and peripheral sensory neuropathy
Hypersensitivity+*
Hypersensitivity SMQ (broad and narrow) and Anaphylactic Reactions 
SMQ (broad and narrow)*
Pulmonary events+
Interstitial lung disease SMQ (narrow) 
All definitions based on MedDRA vs 24.0 or higher, SMQ=Standard MedDRA Query
+
Grouped AE terms
*
For the category of Hypersensitivity+, only events whose onset dates are on the day of or 1 day after study drug 
administration are included.
9.4.
Death
All-cause deaths will be summarized (including presentation of causes of death), and deaths 
within 30 days of the last dose of study drug will be summarized by treatment arm. A listing of 
all death information will be generated.
9.5.
Clinical Laboratory 
Routine safety laboratories, based on hematology and routine serum chemistry data (including 
but not limited to glucose, BUN, total bilirubin, AST, ALT, LDH, alkaline phosphatase, serum 
albumin, total protein, Na, K, calcium, Cl, magnesium, and phosphate), will be summarized 
using values at each visit and change from baseline using descriptive statistics. Laboratory test 
results for lab parameter including but not limited to platelets, neutrophils, white blood count, 
lymphocytes, and hemoglobin will be graded according to NCI-CTCAE v5.0 severity grade.  
Shift tables from baseline to the worst NCI-CTCAE grade observed on-treatment will be 
tabulated for each lab parameter. For parameters whose CTCAE scales do not exist, the 
proportion of subjects with abnormal values will be summarized by treatment arm.
Clinical laboratory data results will be reported in standard international units. Baseline is 
defined as the last observation occurring prior to the first treatment administration of study drug.
If a lab value is reported using a non-numeric qualifier (eg, less than [<] a certain value, or 
greater than [>] a certain value), the given numeric value will be used in the summary statistics, 
ignoring the non-numeric qualifier. Any other manipulation related to lab data not documented 
here will be specified in the ADaM specification.


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9.6.
Vital Signs
Both actual and change-from-baseline data on vital signs (heart rate, systolic and diastolic blood 
pressure, respiratory rate, and body temperature) will be summarized using descriptive statistics 
by treatment group for each study time-point.
All the collected information will be presented for each subject in a by-subject data listing.
9.7.
Electrocardiograms
Descriptive statistics for the actual values and changes from baseline over time will be 
summarized for the ECG parameters including Heart Rate, QT, PR, QRS and QTcF correction.
The proportion of patients with maximum post-baseline absolute QTcF intervals who fall into 
the following categories will be presented:

≤ 450 msec

> 450 msec

> 450 to ≤ 480 msec

> 480 msec

> 480 to ≤ 500 msec

> 500 msec
The proportion of patients who have a maximum post-baseline increase from baseline in QTcF 
intervals of the following categories will be presented:

≤ 30 msec

> 30 msec

>30 to ≤ 60 msec

> 60 msec
The shift table of overall interpretation (‘Normal,’ ‘Abnormal, not clinically significant,’ and 
‘Abnormal, clinically significant’) from baseline to post-baseline evaluation will also be 
provided by treatment arm and by overall.
A listing will be produced for ECG parameters along with any investigator comments that may 
be provided.


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9.8.
ECOG performance status
Shift tables from screening to best post-baseline value will be displayed by treatment arm for the 
safety population. A listing for ECOG grades will be provided as well.
9.9.
Physical Examination and Pregnancy Test
A by-subject listing for each treatment arm will be generated according to the body system and 
presented for any clinically significant findings from physical examination.
The pregnancy test results will be listed for each treatment arm, by subject, indicating the cycle, 
the date of the test, the test results, and the reason for not performing the test.


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10.
METHODS FOR HANDLING MISSING DATA
Missing normal ranges for laboratory parameters
When either the lower limit of normal, the upper limit of normal or both are missing or are not 
machine readable, a standardized reference range will be used.
Missing Data Imputation for Adverse Event/Concomitant Medication Start Dates
1) Missing day only

If the month and year of the AE/the concomitant medication are the same as the month 
and year of the first IMMU-132 dose date, the first dose date day will be used.

If the month and year are before the month and year of the first dose date, the first day of the 
month will be assigned to the missing day.

If the month and year are after the month and year of the first dose date, the first day of the 
month will be assigned to the missing day.
2) Missing day and month

If the year is the same as the year of the first dose date, the first dose date day and month 
will be used.

If the year is prior to the year of the first dose date, December 31 will be assigned to the 
missing fields.

If the year is after the year of the first dose date, January 1 will be assigned to the missing 
fields.
3) Missing day, month, and year

The first dose date will be used.
The imputed start date should be prior or equal to the end date of the AE or medication.
Missing Data Imputation for Missing Adverse Event/Concomitant Medication Stop Date
4) Missing day only

The month and year are the same as the month and year of the first dose date: use the last 
date of the month.

The month and year are before the month and year of the first dose date: use the last date 
of the month.

The month and year are after the month and year of the first dose date: use the last date of 
the month.


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5) Missing day and month

The year is the same as the year of the first dose date: use December 31.
6) Missing year
Uncertain: unable to impute.
7) Missing month

The year is the same as the year of the first dose date: use December.

The year is before the year of the first dose date: use December.

The year is after the year of the first dose date: use December.
8) Missing month and year
Uncertain: unable to impute
9) Missing day and year
Uncertain: unable to impute
10) Missing day, month, year
This event is ongoing.
If the death date is available and the imputed end date is after the death date, the death date will 
be used.
If the imputed end date is before the start date of the AE or medication, then make end date 
equals to start date.


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11.
CHANGES TO ANALYSIS SPECIFIED IN PROTOCOL
In the protocol, at the time of the primary PFS (final) analysis, OS will only be summarized 
descriptively, while the OS 1st interim analysis was estimated to occur after the primary PFS 
(final) analysis. However, as of 03Jan22, the targeted number of events required for the first 
interim OS analysis has been reached. At this time, 329 events for the final PFS analysis have 
been reached. Therefore in this SAP, the Sponsor plans to conduct the final (and only) analysis 
for PFS and the first interim superiority analysis for OS together. The prespecified PFS and OS 
analyses will be provided in a combined data package.
The PFS per LIR is a planned analysis as described in Section 9.5 of the protocol, but it is not 
included as an endpoint in protocol Section 4.3.1. PFS per LIR is added as secondary endpoint in 
Section 4.2 of this SAP. 
The sensitivity analyses for PFS per LIR is included in Section 9.5.3 in the protocol. Since 
sensitivity analyses are only required for primary endpoint of PFS per BICR and PFS per LIR is 
a secondary endpoint, sensitivity analyses for PFS per LIR are not planned in the SAP.


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12.
REFERENCES
Brookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics 
1982;38:29-41.
Clopper CJ, Pearson ES. The Use of Confidence or Fiducial Limits Illustrated in the Case of the 
Binomial. Biometrika 1934;26 (4):404-13.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New Response 
Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (Version 1.1). 
Eur J Cancer 2009;45 (2):228-47.
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