A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women With Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE)
Phase: PHASE3
Conditions: Breast Cancer
Sponsor: Amgen

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Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 1 of 56 
CONFIDENTIAL 
 
 
Amendment 4 
Protocol Title:  A Randomized, Double-Blind, Placebo-Controlled, Multi-Center 
Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage 
Breast Cancer at High Risk of Recurrence (D-CARE) 
 
Amgen Protocol Number (Denosumab) 20060359 
IND # 9838 
EudraCT number 2009-011299-32 
 
Amendment Date: 
17 October 2016 
Rationale: 
The D-CARE study has been ongoing since January 2010.  During the course of the 
study, a considerable gap developed between the expected and observed number of 
BMFS as well as DFS events (primary and secondary endpoints, respectively).  There 
are several reasons that may explain the divergence of the observed event rate from the 
expected event rate. 
Epidemiologic studies have demonstrated that the recurrence risk in breast cancer is 
highest during the first 3 to 5 years, with a peak at about 18 months after diagnosis 
(Cheng et al, 2012; Demicheli et al, 1996).  During initial protocol development, a linear 
event rate was assumed.  Furthermore, in recent years, the adoption of more effective 
therapies, including optimization of aromatase inhibitor therapy for hormone-positive 
disease and the widespread use of anti-HER2 therapy for HER2 positive breast cancer, 
may have contributed to lower disease recurrence overall. 
Based on the current BMFS event total and BMFS event rate, there will be a substantial 
delay in the time to reach the BMFS event target for the primary analysis, and there is 
considerable risk of continued delays.  Moreover, based on the DFS event total and 
event rate, it appears that the DFS event target required for the primary analysis will not 
be reached at all.  The D-CARE steering committee, an advisory group of key 
investigators participating in the study, recommended that a landmark primary analysis 
triggered when all enrolled subjects have the opportunity to complete 5 years of 
treatment on investigational product would be the best approach for the study analysis 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 2 of 56 
CONFIDENTIAL 
 
 
given the considerable challenges to achieving event targets.  The 5-year mark is also 
typically used in clinical trials. 
Therefore, this protocol is being amended to: 
• 
Change the primary analysis from an event-driven analysis to a landmark 
(time-based) analysis, triggered when all subjects have the opportunity to complete 
5 years treatment with investigational product. 
• 
Remove the second interim analysis from the study to avoid the situation whereby 
the primary analysis and second interim analysis occur within a short period of time. 
• 
Remove the open-label phase from the study.  The open-label period would only 
apply if during the course of the blinded treatment phase, denosumab was 
determined to be superior and have a positive benefit/risk profile compared to 
placebo.  The read-out would occur at the interim analyses.  Because the second IA 
was removed, the open-label period is also removed since all subjects will have 
completed the blinded study treatment prior to the primary analysis. 
• 
Redefine long-term follow-up visit frequency and assessments before and after the 
primary analysis cut-off date to avoid unnecessary data collection and burden to 
sites and subjects. 
• 
Update protocol to align with the current protocol template, such as, safety definition 
and reporting language (as well as pregnancy and lactation reporting forms), and 
publication policy. 
 
 
 

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Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 4 of 56 
CONFIDENTIAL 
 
 
Section:  Title Page 
Add: 
Amendment 4 Date: 
 
17 October 2016 
Section:  Investigator’s Agreement, For Japanese Sites Only 
Replace: Vice President,  
 
Clinical Development Department II 
 
R&D Division, Daiichi Sankyo Co., Ltd. 
With: 
Vice President,  
 
Oncology Clinical Development Department 
 
Daiichi Sankyo Co., Ltd. 
Section:  Synopsis, Study Design, Paragraph 2 
Add: 
Subjects who develop bone metastasis will permanently discontinue 
investigational treatment, complete the End of Treatment Phase (EOTP) visit, 
and enter long-term follow-up (LTFU) upon documented evidence (per 
central imaging analysis or biopsy).  For an individual subject, the 
maximum duration of LTFU after completing the EOTP visit is 5 years 
(total study duration for an individual subject is up to 10 years from the 
date of randomization). 
Section:  Synopsis, Study Design, Paragraph 3 
Delete: 
After completing the treatment phase of the study, subjects will be followed 
by clinic visit or telephone contact approximately monthly for 6 months to 
assess clinical outcomes, approximately every 3 months thereafter to assess 
SREs, hypercalcemia, disease recurrence status, and survival (until 
documented evidence of bone metastasis), and approximately every 6 
months thereafter to assess SREs, hypercalcemia, and survival, for up to 10 
years (120 months) from the date of randomization. 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 5 of 56 
CONFIDENTIAL 
 
 
Section:  Synopsis, Study Design, Paragraphs 4 and 5 
Replace: A data monitoring committee (DMC) external to Amgen and external to 
Daiichi Sankyo Co., Ltd. will review safety data at regular intervals, as 
outlined in the DMC charter (approximately twice yearly; the start date will 
depend on subject accrual rates), and will conduct two interim analyses of 
efficacy; the first after approximately 367 subjects have developed bone 
metastasis or died, and approximately 555 subjects have developed any 
disease recurrence or died, whichever comes last; and the second after 
approximately 551 subjects have developed bone metastasis or died, and 
approximately 833 subjects have developed any disease recurrence or died, 
whichever comes last.  The respective interim analyses may be conducted 
early, as soon as approximately 6 months after the sufficient event number 
has been reached for either BMFS or DFS in the full study population, even if 
the event number for the other endpoint has not been reached. 
 
The primary analysis will be conducted after approximately 735 subjects have 
developed bone metastasis or died, and approximately 1110 subjects in the 
full study population and 512 subjects in the postmenopausal subset have 
developed any disease recurrence or died, whichever comes last.  Subjects 
will remain on blinded treatment until the primary analysis is completed.  If 
denosumab is determined to be superior and have a positive benefit/risk 
profile compared with placebo, then all subjects, who remain on blinded study 
treatment, will be offered open-label denosumab 120 mg SC according to 
their scheduled study procedures, for a total treatment duration of 5 years 
from their date of first dose of investigational product (study day 1), or until 
documented evidence of bone metastasis (per investigator report), or until 
denosumab is commercially available for the treatment of early-stage breast 
cancer, whichever comes first.  If denosumab is not determined to have a 
positive benefit/risk profile compared with placebo, then all subjects will 
complete the EOTP visit and enter follow-up for survival (approximately every 
6 months for up to 10 years [120 months] from the date of randomization). 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 6 of 56 
CONFIDENTIAL 
 
 
With: 
A data monitoring committee (DMC) external to Amgen and external to 
Daiichi Sankyo Co., Ltd. will review safety data at regular intervals, as 
outlined in the DMC charter (approximately twice yearly; the start date will 
depend on subject accrual rates), and will conduct 1 interim analysis of 
efficacy after approximately 367 subjects have developed bone metastasis or 
died, and approximately 555 subjects have developed any disease 
recurrence or died, whichever comes last.  This interim analysis may be 
conducted early, as soon as approximately 6 months after the sufficient event 
number has been reached for either BMFS or DFS in the full study 
population, even if the event number for the other endpoint has not been 
reached. 
 
The primary analysis will be conducted after all enrolled subjects have had 
the opportunity to complete 5 years of treatment from study day 1. 
Section:  Synopsis, Investigational Product Dosage and Administration, Paragraph 4 
Delete: 
Subjects will remain on blinded treatment until the primary analysis is 
completed.  If denosumab is determined to be superior and have a positive 
benefit/risk profile compared with placebo, then all subjects, who remain on 
blinded study treatment, will be offered open-label denosumab 120 mg SC 
according to their scheduled study procedures, for a total treatment duration 
of 5 years from their first dose of investigational product (study day 1), or until 
documented evidence of bone metastasis (per investigator report), or until 
denosumab is commercially available for the treatment of early-stage breast 
cancer, whichever is earlier.  If denosumab is not determined to have a 
positive benefit/risk profile compared with placebo, then all subjects will 
complete the EOTP visit and enter follow-up for survival (approximately every 
6 months for up to 10 years [120 months] from the date of randomization). 
Section:  Synopsis, Investigational Product Dosage and Administration, Paragraph 4 
Add: 
Administration of investigational products (denosumab or placebo) will be 
withheld for any subject who experiences a grade 3 or 4 adverse event per 
Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 
reported by the investigator as related to investigational product, atypical 
femoral fracture (AFF) or osteonecrosis of the jaw (ONJ), as determined by 
the investigator or by an independent expert panel. 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 7 of 56 
CONFIDENTIAL 
 
 
Section:  Synopsis, Key Study Procedures, Paragraph 4 
Replace: Treatment and Follow-up: Subjects will receive investigational product for up 
to 5 years from study day 1 (treatment period), and will then be followed by 
clinic visit or telephone contact approximately monthly (Q4W ± 7 days) for 
six months to assess clinical outcomes (SREs, hypercalcemia of malignancy, 
concomitant medications, breast cancer therapy, patient-reported outcomes 
[BPI-SF, EQ-5D], disease recurrence status [until documented evidence of 
bone metastasis], and survival), approximately every 3 months (every 
12 weeks ± 14 days) thereafter to assess SREs, hypercalcemia, disease 
recurrence status, and survival (until documented evidence of bone 
metastasis), and approximately every 6 months (± 1 month) thereafter to 
assess SREs, hypercalcemia, and survival, for up to 10 years (120 months) 
from the date of randomization. 
With: 
Treatment and Follow-up:  Subjects will receive investigational product for up 
to 5 years from study day 1 (treatment period), and will then enter LTFU for 
approximately 5 years (60 months) following the EOTP visit.  The 
expected total study duration for an individual subject is up to 10 years 
from the randomization date. 
Section:  Synopsis, Key Study Procedures, Paragraph 7 
Delete: 
Blinded Treatment Phase:  The following assessments will be performed at 
various visits (see Appendix A): 
Section:  Synopsis, Key Study Procedures, Paragraph 8 
Delete: 
Open-Label Treatment Phase: The following assessments will be performed 
at various visits (see Appendix A): ECOG performance status; physical 
examination including vital signs (temperature, pulse, blood pressure, 
respiratory rate) and weight; oral examination; clinical fractures and SREs; 
breast cancer therapy; concomitant medications; hematology; serum 
chemistry; denosumab PK (subjects participating in the PK substudy who 
received blinded denosumab on study); anti-denosumab antibodies.  Adverse 
events and concomitant medications will be recorded throughout the study. 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 8 of 56 
CONFIDENTIAL 
 
 
Section:  Synopsis, Statistical Considerations, Paragraph 1 
Replace: The key secondary objective is to compare the treatment effect of 
denosumab with that of placebo on prolonging DFS in the full study 
population or in the postmenopausal subset. 
With: 
The key secondary objective is to compare the treatment effect of 
denosumab with that of placebo on prolonging DFS in the full study 
population and in the postmenopausal subset. 
Section:  Synopsis, Statistical Considerations, Paragraphs 2 to 3 
Replace: Key efficacy analyses: Two interim analyses of efficacy will be conducted; the 
first after approximately 367 subjects have developed bone metastasis or 
died, and approximately 555 subjects in the full study population have 
developed any disease recurrence or died, whichever comes last; and the 
second after approximately 551 subjects have developed bone metastasis or 
died, and approximately 833 subjects in the full study population have 
developed any disease recurrence or died, whichever comes last.  The 
respective interim analyses may be conducted early, as soon as 
approximately 6 months after the sufficient event number has been reached 
for either BMFS or DFS in the full study population, even if the event number 
for the other endpoint has not been reached. 
 
The primary analysis will be performed after approximately 735 subjects have 
developed bone metastasis or died, and approximately 1110 subjects in the 
full study population and approximately 512 subjects in the postmenopausal 
subset have developed any disease recurrence or died, whichever comes 
last. 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 9 of 56 
CONFIDENTIAL 
 
 
With: 
Key efficacy analyses:  One interim analysis of efficacy will be conducted; 
after approximately 367 subjects have developed bone metastasis or died, 
and approximately 555 subjects in the full study population have developed 
any disease recurrence or died, whichever comes last.  This interim analysis 
may be conducted early, as soon as approximately 6 months after the 
sufficient event number has been reached for either BMFS or DFS in the full 
study population, even if the event number for the other endpoint has not 
been reached. 
 
The primary analysis will be conducted after all enrolled subjects have 
had the opportunity to complete 5 years of treatment from study day 1. 
 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 10 of 56 
CONFIDENTIAL 
 
 
Section:  Study Schema 
Replace: 
 
 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 11 of 56 
CONFIDENTIAL 
 
 
With: 
 
 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 12 of 56 
CONFIDENTIAL 
 
 
Section:  Study Glossary 
Add: 
EU 
European Union 
LTFU 
Long-term follow-up 
Section:  Study Glossary 
Replace: 
Primary Analysis Data 
Cut-off Date 
(primary completion) 
Amgen will set a primary analysis data cut-off date in anticipation of 
approximately 735 subjects having developed bone metastasis or 
died, and approximately 1110 subjects in the full study population 
and 512 subjects in the postmenopausal subset having developed 
any disease recurrence or died, whichever comes last.  The primary 
analysis will be based on the data from randomization through the 
primary analysis data cut-off date. 
With: 
Primary Analysis Data 
Cut-off Date 
(primary completion) 
Amgen will set a primary analysis data cut-off date in anticipation of 
all enrolled subjects having had the opportunity to complete 
5 years of treatment from study day 1.  The primary analysis will 
be based on the data from randomization through the primary 
analysis data cut-off date. 
Section:  Study Glossary 
Delete: 
End of Blinded Treatment 
Phase  
(for the clinical study) 
If denosumab is determined to be superior and have a positive 
benefit/risk profile compared with placebo, then the end of the 
blinded treatment phase is defined as approximately 12 weeks after 
the last dose of investigation product in the blinded treatment phase.  
If the benefit/risk profile is not positive, then the end of the blinded 
treatment phase is defined as approximately 4 weeks after the last 
dose of denosumab in the blinded treatment phase. 
Open-Label Treatment 
Phase 
If denosumab is determined to be superior and have a positive 
benefit/risk profile compared with placebo, then all subjects, who 
remain on blinded study treatment, will be offered open-label 
denosumab 120 mg SC according to their scheduled study 
procedures, for a total treatment duration of 5 years (approximately 
60 months) from their study day 1, or until documented evidence of 
bone metastasis (per investigator report), or until denosumab is 
commercially available for the treatment of early-stage breast 
cancer, whichever comes first. 
 
 
 

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Section:  Study Glossary 
Delete: 
End of Treatment Phase 
(EOTP)  
(for an individual 
participant) 
An individual subject may receive investigational product for up to 
5 years (ie, 60 months) from the day of first dose of investigational 
product (study day 1), or until documented evidence of bone 
metastasis (per central imaging analysis or biopsy), or (for subjects 
on open-label denosumab only) until documented evidence of bone 
metastasis (per investigator report), or until denosumab is 
commercially available for the treatment of early-stage breast 
cancer, whichever is earlier.  See Section 3.4.1. 
Section:  2.6.  Hypotheses, Paragraph 2 
Replace: It is anticipated that the true HR of denosumab compared with placebo is 
0.83 in the full study population or in the postmenopausal subset. 
With: 
It is anticipated that the true HR of denosumab compared with placebo is 
0.83 in the full study population and 0.76 in the postmenopausal subset. 
Section:  3.1.  Study Design, Paragraph 1 
Delete: 
Approximately 4,500 subjects will be randomized in a 1:1 ratio to receive 
denosumab 120 mg or matching placebo SC Q4W (± 7 days) for 
approximately 6 months followed by denosumab 120 mg or matching placebo 
SC every Q3M (ie, every 12 weeks ± 14 days) for 4½ years (approximately 
54 months), for a total treatment duration of 5 years (approximately 
60 months), or until the end of the blinded treatment phase, whichever is 
earlier. 
Section:  3.1.  Study Design, Paragraphs 3 to 4 
Replace: A data monitoring committee (DMC) external to Amgen and external to 
Daiichi Sankyo Co., Ltd. will review safety data at regular intervals, as 
outlined in the DMC charter (approximately twice yearly; the start date will 
depend on subject accrual rates).  This external DMC will conduct two interim 
analyses of efficacy; the first after approximately 367 subjects have 
developed bone metastasis or died, and approximately 555 subjects have 
developed any disease recurrence or died, whichever comes last; and the 
second after approximately 551 subjects have developed bone metastasis or 
died, and approximately 833 subjects have developed any disease 
recurrence or died, whichever comes last.  To ensure timely conduct of the 
 
 
 

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respective interim analyses, the interim analyses may be conducted early, as 
soon as approximately 6 months after the sufficient event number has been 
reached for either BMFS or DFS in the full study population, even if the event 
number for the other endpoint has not been reached. 
 
The primary analysis will be conducted after approximately 735 subjects have 
developed bone metastasis or died, and approximately 1110 subjects in the 
full study population and 512 subjects in the postmenopausal subset have 
developed any disease recurrence or died, whichever comes last. Subjects 
will remain on blinded treatment until the primary analysis is completed. If 
denosumab is determined to be superior and have a positive benefit/risk 
profile compared with placebo, then all subjects, who remain on blinded study 
treatment, will be offered open-label denosumab 120 mg SC according to 
their scheduled study procedures, for a total treatment duration of 5 years 
from their day of first dose of investigational product (study day 1), or until 
documented evidence of bone metastasis (per investigator report), or until 
denosumab is commercially available for the treatment of early-stage breast 
cancer, whichever comes first.  If denosumab is not determined to have a 
positive benefit/risk profile compared with placebo, then all subjects will 
complete the EOTP visit and enter follow-up for survival (approximately every 
6 months for up to 10 years [120 months] from the date of randomization). 
With: 
A data monitoring committee (DMC) external to Amgen and external to 
Daiichi Sankyo Co., Ltd. will review safety data at regular intervals, as 
outlined in the DMC charter (approximately twice yearly; the start date will 
depend on subject accrual rates).  This external DMC will conduct 1 interim 
analysis of efficacy after approximately 367 subjects have developed bone 
metastasis or died, and approximately 555 subjects have developed any 
disease recurrence or died, whichever comes last.  To ensure timely conduct 
of the interim analysis, the interim analysis may be conducted early, as 
soon as approximately 6 months after the sufficient event number has been 
reached for either BMFS or DFS in the full study population, even if the event 
number for the other endpoint has not been reached. 
 
The primary analysis will be conducted after all enrolled subjects have had 
the opportunity to complete 5 years of treatment from study day 1. 
 
 
 

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Section:  3.3.  Number of Subjects, Paragraph 1 
Delete: 
Participants in this clinical investigation shall be referred to as “subjects”. 
Approximately 2,250 subjects will be randomized to each treatment group, for 
a total planned sample size of approximately 4,500 subjects.  Amgen may 
choose to increase sample size to ensure timely completion of the study, e.g. 
if the event rate is lower than expected. Refer to Section 10.3 for details on 
the rationale for the number of subjects. 
Section:  3.4.1.  Study Duration for Individual Participants, Paragraph 1 
Delete: 
An individual subject may receive investigational product treatment for up to 
5 years (ie, 60 months) from the day of first dose of investigational product 
(study day 1), or until documented evidence of bone metastasis (per central 
imaging analysis or biopsy), or (for subjects on open-label denosumab only) 
until documented evidence of bone metastasis (per investigator report), or 
until denosumab is commercially available for the treatment of early-stage 
breast cancer, whichever is earlier (treatment phase). 
Section:  3.4.1.  Study Duration for Individual Participants, Paragraph 2 
Replace: After completing the treatment phase of the study, subjects will be followed 
by clinic visit or telephone contact approximately monthly (Q4W ± 7 days) for 
six months to assess clinical outcomes.  After the first six months, subjects 
will be followed approximately every 3 months (every 12 weeks ± 14 days) 
thereafter to assess SREs, hypercalcemia, disease recurrence status, and 
survival.  If there is documented evidence of bone metastasis, the frequency 
of follow-up visits will change to approximately every 6 months (± 1 month) to 
assess SREs, hypercalcemia, and survival for up to 10 years (120 months) 
from the date of randomization. 
With: 
After completing the treatment phase of the study, subjects will be followed 
by clinic visit or telephone contact for up to 5 years (60 months) from the 
EOTP visit (total study duration for an individual subject is up to 
10 years from the date of randomization).  Follow-up procedures are 
detailed in Section 7.1.4. 
 
 
 

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Section:  3.4.2.  Duration of the Clinical Study, Paragraph 1 
Replace: The anticipated duration of the blinded treatment phase is approximately 
93 months (ie 7 years and 9 months) from first subject enrolled.  This 
represents time to recruit approximately 4,500 subjects (approximately 
30 months) and time for approximately 735 subjects to experience bone 
metastasis or death, and for approximately 1110 subjects in the full study 
population and 512 subjects in the postmenopausal subset to experience any 
disease recurrence or death, whichever comes last, as well as continued 
blinded treatment until the primary analysis is complete and the benefit/risk 
profile of denosumab is determined.  Actual study duration may vary 
depending on observed event rates. 
With: 
The anticipated duration from first subject enrolled to the primary 
completion of the study is approximately 87 months (ie, 7 years and 
3 months).  This represents time to recruit approximately 4,500 subjects 
(approximately 27 months) and time for all subjects to have the 
opportunity to complete 5 years of blinded treatment. 
Section:  3.4.2.  Duration of the Clinical Study, Paragraph 2 
Delete: 
Amgen will monitor the overall event rate pooled by treatment group, and will 
set a data cut-off date for the primary analysis in anticipation of approximately 
735 subjects having experienced bone metastasis or death, and 
approximately 1110 subjects in the full study population and 512 subjects in 
the postmenopausal subset having experienced disease recurrence or death.  
Amgen may choose to increase the sample size in order to ensure timely 
completion of the study. 
Section:  3.4.2.  Duration of the Clinical Study, Paragraph 2 
Replace: The anticipated overall duration of the clinical study, including the recruitment 
period (approximately 2.5 years [30 months]), the treatment period 
(approximately 5 years [60 months], and the follow-up period (approximately 
5 years [60 months]), will be approximately 12.5 years or approximately 
150 months. 
 
 
 

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With: 
The anticipated overall duration of the clinical study, including the recruitment 
period (approximately 2.5 years [27 months]), the treatment period 
(approximately 5 years [60 months]), and the follow-up period (approximately 
5 years [60 months]), will be approximately 12.5 years or approximately 
150 months. 
Section:  3.4.3.  End of Study (End of the Clinical Study), Paragraph 1 
Replace: Amgen will set a primary analysis data cut-off date in anticipation of 
approximately 735 subjects having developed bone metastasis or died, and 
approximately 1110 subjects in the full study population and 512 subjects in 
the postmenopausal subset having developed any disease recurrence or 
died, whichever comes last.  The primary analysis will be based on the data 
from randomization through the primary analysis data cut-off date and is 
considered the primary completion of the study. 
With: 
The primary analysis will be conducted after all enrolled subjects have 
had the opportunity to complete 5 years of treatment from study day 1.  
The primary analysis will be based on the data from randomization through 
the primary analysis data cut-off date and is considered the primary 
completion of the study. 
Section:  3.4.3.  End of Study (End of the Clinical Study), Paragraph 2 
Replace: The End of Study (End of the Clinical Study) is defined as the date that the 
last subject is assessed in the follow-up phase.  With 30 months of enrollment 
and the last subject anticipated to be on study for 10 years (ie., 120 months), 
the end of study is anticipated to be approximately 12.5 years (ie., 
approximately 150 months) from the first subject enrolled. 
With: 
The End of Study (End of the Clinical Study) is defined as the date that the 
last subject is assessed in the follow-up phase.  With 27 months of enrollment 
and the last subject anticipated to be on study for up to 10 years (ie, 
120 months), the end of study is anticipated to be approximately 12.5 years 
(ie, approximately 150 months) from the first subject enrolled. 
 
 
 

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Section:  6.1.  Investigational Product Dosage, Administration, and Schedule, 
Paragraph 3 
Delete: 
The total treatment duration will be 5 years (approximately 60 months) or until 
the end of the blinded treatment phase, whichever is earlier. 
Section:  6.5.  Dose Escalation and Dose Stopping Rules, Paragraph 2 
Add: 
Administration of investigational product (denosumab or placebo) will be 
withheld for any subject who experiences a grade 3 or 4 adverse event per 
National Cancer Institute Common Terminology Criteria for Adverse Events 
(NCI CTCAE) version 3.0 reported by the investigator as related to 
investigational product, atypical femoral fracture (AFF), or osteonecrosis of 
the jaw (ONJ), as determined by the investigator or by an independent expert 
panel. 
Section:  7.1.2.1.  Study Treatment, Paragraph 1 
Delete: 
Blinded Treatment Phase 
 
Study treatment (investigational product:  denosumab at a dose of 120 mg or 
matching placebo) will be administered by a licensed healthcare professional 
SC Q4W (±7 days, at least 3 weeks apart; see Section 6.1) for approximately 
6 months, followed by investigational product SC Q3M (ie, every 
12 weeks ± 14 days) for 4½ years (approximately 54 months), for a total 
treatment duration of 5 years (approximately 60 months), or until documented 
evidence of bone metastasis (per central imaging analysis or biopsy), or until 
the end of the blinded treatment phase, whichever is earlier.  During the first 
approximate 6 months of treatment, investigational product may be 
administered Q3W to subjects receiving or scheduled to receive Q3W 
adjuvant/neoadjuvant chemotherapy (see Section 6.1).  There must be at 
least a 3-week interval between administrations of investigational product. 
 
Open-Label Treatment Phase 
 
Subjects will remain on blinded treatment until the primary analysis is 
completed.  If denosumab is determined to be superior and have a positive 
benefit/risk profile compared with placebo, then all subjects, who remain on 
blinded study treatment, will be offered open-label denosumab 120 mg SC 
according to their scheduled study procedures, for a total treatment duration 
 
 
 

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of 5 years from their date of first dose of investigational product (study day 1), 
or until documented evidence of bone metastasis (per investigator report), or 
until denosumab is commercially available for the treatment of early-stage 
breast cancer, whichever is earlier. 
Section:  7.1.3.  End of Treatment Phase (EOTP), Paragraphs 2 to 4 
Delete: 
If denosumab is not determined to have a positive benefit/risk profile 
compared with placebo, then all subjects will complete the EOTP visit 4 
weeks (+ 7 days) after their last dose of investigational product.  
 
All EOTP assessments must be completed (unless done within the prior 
4 weeks), except imaging assessments, which do not need to be repeated if 
completed within the prior 6 months (ie, 24 weeks).  
 
If denosumab is not determined to have a positive benefit/risk profile 
compared with placebo, then no imaging will be required at the EOTP visit. 
Section:  7.1.4.  Follow-up Procedures, entire section 
Replace: Blinded Treatment Phase 
 
After completing the treatment phase of the study, subjects will be followed 
by clinic visit or telephone contact approximately monthly (Q4W ± 7 days) for 
six months to assess clinical outcomes (SREs, hypercalcemia of malignancy, 
concomitant medications, breast cancer therapy, patient-reported outcomes 
[BPI-SF, EQ-5D], disease recurrence status [until documented evidence of 
bone metastasis {per central imaging analysis or biopsy}] and survival) and 
approximately every 3 months (every 12 weeks ± 14 days) thereafter to 
assess SREs, hypercalcemia, disease recurrence status, and survival (until 
documented evidence of bone metastasis [per central imaging analysis or 
biopsy]), and approximately every 6 months (± 1 month) thereafter to assess 
SREs, hypercalcemia, and, survival, for up to 10 years (120 months) from the 
date of randomization. 
 
Imaging assessments will continue during follow-up per the schedule of 
assessments (Appendix A), until documented evidence of disease recurrence 
in the bone (per central imaging analysis or biopsy).  See Section 7.2.9 for 
details. 
 
 
 

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One serum sample to evaluate for the presence of anti-denosumab 
antibodies will be collected approximately 6 months (24 weeks ± 14 days) 
after the last investigational product administration.  In addition, biomarker 
samples will be taken at the time of disease recurrence (including both first 
disease recurrence, and first disease recurrence in the bone, if applicable). 
 
Open-Label Treatment Phase 
 
After completing the open-label treatment phase of the study, subjects will be 
followed by clinic visit or telephone contact approximately every 3 months 
(every 12 weeks ± 14 days) to assess disease recurrence status and survival 
(until documented evidence of bone metastasis [per investigator report]), and 
approximately every 6 months (± 1 month) thereafter to assess survival, for 
up to 10 years (120 months) from the date of randomization. 
 
There will be no scheduled imaging assessments during the open-label 
treatment phase. 
 
One serum sample to evaluate for the presence of anti-denosumab 
antibodies will be collected approximately 6 months (24 weeks ± 14 days) 
after the last investigational product administration.  In addition, biomarker 
samples will be taken at the time of disease recurrence (including both first 
disease recurrence, and first disease recurrence in the bone, if applicable). 
 
Follow-up if Benefit/Risk Profile is Not Determined to be Positive 
 
If denosumab is not determined to have a positive benefit/risk profile 
compared with placebo, then all subjects will complete the EOTP visit and 
enter follow-up for survival (approximately every 6 months for up to 10 years 
[120 months] from the date of randomization).  
 
One serum sample to evaluate for the presence of anti-denosumab 
antibodies will be collected approximately 6 months (24 weeks ± 14 days) 
after the last investigational product administration. 
 
There will be no scheduled imaging assessments, and no other scheduled 
procedures. 
 
 
 

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With: 
After completing the treatment phase of the study, subjects will then enter 
LTFU for approximately 5 years (60 months) following the EOTP visit.  
The study requirements during LTFU are different before and after 
primary analysis data cut-off date and are detailed in Section 7.1.4.1 
(before primary analysis data cut-off date) and Section 7.1.4.2 (after 
primary analysis data cut-off date). 
 
7.1.4.1.  LTFU Requirements Prior to the Primary Analysis Data Cut-off 
Date 
 
All subjects (including subjects with documented evidence of bone 
metastasis) should be followed by clinic visit or telephone contact 
every 3 months (every 12 weeks ± 14 days) for approximately 6 months 
(ie, first 2 visits of LTFU following EOTP). 
• 
The following assessments are required: 
− 
clinical fractures/SREs  
− 
hypercalcemia of malignancy  
− 
breast cancer therapy  
− 
concomitant medications  
− 
patient-reported outcomes (BPI-SF, EQ-5D)  
− 
disease recurrence status (until documented evidence of bone 
metastasis [per central imaging analysis or biopsy]).  Not required 
for subjects with documented evidence of bone metastasis 
− 
survival 
All subjects without documented evidence of bone metastasis:  
following the completion of the initial 6 month LTFU period, subjects 
should be followed by clinic visit or telephone contact every 3 months 
(every 12 weeks ± 14 days). 
• 
The following assessments are required: 
− 
clinical fractures/SREs 
− 
hypercalcemia 
− 
disease recurrence status (until documented evidence of bone 
metastasis [per central imaging analysis or biopsy]) 
− 
survival 
Imaging assessments will continue during LTFU per the schedule of 
assessments (Appendix A), until documented evidence of disease recurrence 
 
 
 

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in the bone (per central imaging analysis or biopsy).  See Section 7.2.9 for 
details. 
Biomarker samples will be taken at the time of disease recurrence (including 
both first disease recurrence, and first disease recurrence in the bone, if 
applicable). 
Subjects with documented evidence of bone metastasis including 
subjects whose bone metastasis is confirmed after the initial 6 month 
(per central imaging analysis or biopsy):  following the completion of 
the initial 6 month LTFU period, subjects should be followed by clinic 
visit or telephone contact every 6 months (± 1 month). 
• 
The following assessments are required: 
− 
SREs 
− 
hypercalcemia 
− 
survival 
 
7.1.4.2.  LTFU Requirements After the Primary Analysis Data Cut-off 
Date 
 
Following the primary analysis data cut-off date, all subjects should 
complete the EOTP visit and will be followed by clinic visit or telephone 
contact every 6 months (± 1 month) for survival only.  All scheduled 
imaging and all other assessments (except survival) will cease after the 
primary analysis data cut-off date. 
Section:  7.2.5.  Adverse Event Collection 
Replace: Exceptions are hypercalcemia of malignancy, clinical fractures, and SREs, 
which will be followed until the End of Study (see Sections 7.2.5.1 and 7.2.6). 
With: 
Exceptions are hypercalcemia of malignancy, clinical fractures, and SREs, 
which will continue to be collected during LTFU prior to primary analysis 
data cut-off date (see Sections 7.2.5.1 and 7.2.6). 
 
 
 

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Section:  7.2.5.1.  Hypercalcemia of Malignancy 
Replace: Clinical events of hypercalcemia of malignancy will be collected on the eCRF 
throughout the study and during the follow-up. 
With: 
Clinical events of hypercalcemia of malignancy will be collected on the eCRF 
throughout the study and during LTFU prior to primary analysis data 
cut-off date. 
Section:  7.2.6.  Clinical Fracture and Skeletal-related Event Collection, 
Paragraphs 6 to 7 
Replace: Information about any new clinical fractures or SREs will be assessed and 
documented on the eCRF at each scheduled clinic visit and during the 
follow-up.  Copies of all radiographic assessments performed to diagnose 
clinical fractures and SREs must be submitted to the central imaging vendor.  
Copies of all screening and on-study radiology, surgery, or pathology reports 
should be kept in the subject’s records regardless if corresponding 
radiographs (or equivalent) are available. 
 
Open-Label Treatment Phase: Radiographic assessments of events incurred 
during the open-label treatment phase will not be submitted to the central 
imaging vendor. 
With: 
Information about any new clinical fractures (prior to the development of 
bone metastasis) or SREs will be assessed and documented on the eCRF 
at each scheduled clinic visit and during LTFU prior to primary analysis 
data cut-off date.  Copies of all radiographic assessments performed to 
diagnose clinical fractures and SREs must be submitted to the central 
imaging vendor.  Copies of all screening and on-study radiology, surgery, or 
pathology reports should be kept in the subject’s records regardless if 
corresponding radiographs (or equivalent) are available. 
 
Radiographic assessments for clinical fractures and SREs collected 
after primary analysis data cut-off date will not be submitted to the 
central imaging vendor. 
 
 
 

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Section:  7.2.8.  Patient Reported Outcomes, Paragraph 2 
Delete: 
Open-Label Treatment Phase: There will be no collection of patient reported 
outcomes during the open-label treatment phase. 
Section:  7.2.9.1.  Disease Assessments (Mammography, Bone Scan, CT/MRI), 
Paragraph 2 
Add: 
All scheduled on-study imaging must be performed within ± 6 weeks of the 
protocol-specified time point, unless performed within the previous 6 months.  
All scheduled imaging will cease after the primary analysis data cut-off 
date. 
Section:  7.2.9.1.  Disease Assessments (Mammography, Bone Scan, CT/MRI), 
Paragraph 3 
Delete: 
Open-Label Treatment Phase: There will be no protocol required imaging 
assessments during the open-label treatment phase. 
Section:  7.2.10.1.  Blood Assessments, Paragraphs 4-8 
Delete: 
Open-Label Treatment Phase: After subjects have been unblinded, there will 
be no scheduled collection of PK samples for subjects, who switch from 
placebo to open-label denosumab.  Subjects, who switch from blinded 
denosumab to open-label denosumab will continue PK sampling per the 
schedule of assessments. 
 
The centers that will participate in this part of the study will be determined at 
the time of site selection, on the basis of center interest, site ability to obtain 
and process serum denosumab concentration samples, and recruitment 
capacity.  A competitive enrollment strategy will be used.  Serum levels for 
denosumab will be obtained in randomized subjects at these centers until 
approximately 120 subjects have been enrolled into the PK portion of the trial 
(optional for subjects). 
 
Anti-denosumab antibodies: Serum for anti-denosumab antibody assay will 
be collected at baseline (prior to administration of the investigational products 
on study day 1), and on study as outlined in the schedule of assessments 
(Appendix A), and one sample during follow-up (approximately 6 months [24 
weeks ± 14 days] after the last investigational product administration). 
 
 
 

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Blood biomarkers and Bone Specific Alkaline Phosphatase (BSAP): Blood for 
biomarker assessments and BSAP will be obtained at baseline (prior to 
administration of the investigational products on study day 1), on study as 
outlined in the schedule of assessments (Appendix A), and upon disease 
recurrence (including both first disease recurrence, and first disease 
recurrence in the bone, if applicable). 
 
Open-Label Treatment Phase: There will be no scheduled biomarker 
assessments during the open-label treatment phase. 
Section:  7.2.10.2.  Urine Assessments, Paragraph 4 
Delete: 
Open-Label Treatment Phase: There will be no scheduled urine assessments 
during the open-label treatment phase. 
Section:  7.2.10.3.  Tumor Samples, Paragraph 2 
Delete: 
Open-Label Treatment Phase: There will be no scheduled tumor sample 
collection during the open-label treatment phase. 
Section:  7.3.1.  Biomarker Development, Paragraph 3 
Delete: 
Open-Label Treatment Phase: There will be no scheduled biomarker 
assessments during the open-label treatment phase. 
Section:  9.1.1.  Adverse Events, Paragraphs 2 to 7 
Replace: This definition of adverse events is broadened in this study to include any 
such occurrence (e.g., sign, symptom, or diagnosis) or worsening of a 
pre-existing medical condition from the time that a subject has signed 
informed consent to the time of randomization to or initiation of investigational 
product.  Worsening indicates that the pre-existing medical condition (e.g., 
diabetes, migraine headaches, gout) has increased in severity, frequency, or 
duration of the condition or an association with significantly worse outcomes. 
 
If infections occur, microbiological investigations (e.g. cultures) should be 
performed as clinically feasible to identify a causative organism, and specific 
data should be reported. 
 
Recurrence of breast cancer should not be reported as an adverse event.  
However, any specific symptoms or sequelae of the disease recurrence (e.g., 
 
 
 

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organ failure, respiratory distress, etc) will be considered adverse events and 
will be captured on the eCRF.   
 
Interventions for pretreatment conditions (e.g., elective surgery) or medical 
procedures that were planned before study enrollment are not considered 
adverse events.   
 
The investigator is responsible for reviewing laboratory test results and 
determining whether an abnormal value in an individual study subject 
represents a change from values before the study.  In general, abnormal 
laboratory findings without clinical significance (based on the investigator's 
judgment) should not be recorded as adverse events; however, laboratory 
value changes requiring therapy or adjustment in prior therapy are 
considered adverse events. 
With: 
The investigator is responsible for ensuring that any adverse events 
observed by the investigator or reported by the subject are recorded in 
the subject’s medical record. 
 
This definition of adverse events is broadened in this study to include any 
such occurrence (eg, sign, symptom, or diagnosis) or worsening of a 
pre-existing medical condition from the time that a subject has signed 
informed consent to the time of randomization to or initiation of investigational 
product.  Worsening indicates that the pre-existing medical condition or 
underlying disease (eg, diabetes, migraine headaches, gout) has increased 
in severity, frequency, and/or duration more than would be expected, 
and/or has an association with a significantly worse outcome than 
expected. 
 
If infections occur, microbiological investigations (eg, cultures) should be 
performed as clinically feasible to identify a causative organism, and specific 
data should be reported. 
 
Recurrence of breast cancer should not be reported as an adverse event.  
However, any specific symptoms or sequelae of the disease recurrence (eg, 
organ failure, respiratory distress, etc) will be considered adverse events and 
will be captured on the eCRF.   
 
 
 

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Interventions for pretreatment conditions (eg, elective surgery) or, medical 
procedures that were planned before study enrollment, are not considered 
adverse events.   
 
The investigator’s clinical judgment is used to determine whether a 
subject is to be removed from treatment due to an adverse event.  In the 
event a subject, or subject’s legally acceptable representative requests 
to withdraw from protocol-required therapies or the study due to an 
adverse event, refer to Section 8.1 for additional instructions on the 
procedures recommended for safe withdrawal from protocol-required 
therapies or the study. 
 
The investigator is responsible for reviewing laboratory test results and 
determining whether an abnormal value in an individual study subject 
represents a clinically significant change from the subject’s baseline 
values.  In general, abnormal laboratory findings without clinical significance 
(based on the investigator's judgment) should not be recorded as adverse 
events; however, laboratory value changes requiring therapy or adjustment in 
prior therapy are considered adverse events.  Where applicable, clinical 
sequelae (not the laboratory abnormality) are to be recorded as the 
adverse event.  The investigator is expected to follow reported adverse 
events until stabilization or reversibility. 
Section:  9.1.2.  Serious Adverse Events, Paragraph 1 
Add: 
A serious adverse event is defined as an adverse event that meets at least 1 
of the following criteria: 
Section:  9.1.2.  Serious Adverse Events, Paragraph 3 
Add: 
Examples include allergic bronchospasm, convulsions, and blood dyscrasias, 
drug-induced liver injury, or events that necessitate an emergency room 
visit, outpatient surgery, or urgent intervention. 
Section:  9.2.  Safety Event Reporting Procedures, Section Title 
Replace: Reporting Procedures for All Adverse Events 
With: 
Safety Event Reporting Procedures 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 28 of 56 
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Section:  9.2.  Safety Event Reporting Procedures 
Add: 
9.2.1 
Adverse Events 
Section:  9.2.2.  Reporting Procedures for Serious Adverse Events, Paragraphs 1 to 4 
Replace: 
9.3 
Serious Adverse Event Reporting Procedures 
 
Serious adverse events will be collected and recorded at least throughout the 
study period, beginning with the signing of the informed consent until the 
EOTP, or for 30 days after the last dose of investigational product for subjects 
who discontinue investigational product before the EOTP.  All serious 
adverse events occurring after the above mentioned criteria will be collected 
and recorded. 
 
All serious adverse events that occur after the subject has signed the 
informed consent form must be submitted to Amgen within 24 hours following 
the investigator’s knowledge of the event via the applicable electronic Serious 
Adverse Event (eSAE) eCRF.  If the electronic data capture (EDC) system is 
unavailable to the site staff to report the Serious Adverse Event, the 
information is to be reported to Amgen via an electronic Serious Adverse 
Event (eSAE) Contingency Report Form within 24 hours of the Investigator’s 
knowledge of the event.  See Appendix G for a sample of the Serious 
Adverse Event Worksheet/electronic Serious Adverse Event Contingency 
Report Form. 
 
New information relating to a previously reported serious adverse event must 
be submitted to Amgen.  All new information for serious adverse events must 
be sent to Amgen within 24 hours following knowledge of the new 
information.  The Investigator may be asked to provide additional follow-up 
information, which may include a discharge summary or extracts from the 
medical record.  Information provided about the serious adverse event must 
be consistent with that recorded on the applicable eCRF (eg, Adverse Event 
Summary eCRF). 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
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Page 29 of 56 
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With: 
9.2.2 
Reporting Procedures for Serious Adverse Events 
 
The investigator is responsible for ensuring that all serious adverse 
events observed by the investigator or reported by the subject that 
occur after signing of the informed consent through the EOTP, or for 
30 days after the last dose of investigational product for subjects who 
discontinue investigational product before the EOTP, are recorded in the 
subject’s medical record and are submitted to Amgen.  All serious 
adverse events must be submitted to Amgen within 24 hours following 
the investigator’s knowledge of the event via the Adverse Event CRF.   
 
All serious adverse events that occur after the subject has signed the 
informed consent form must be submitted to Amgen within 24 hours following 
the investigator’s knowledge of the event via the applicable electronic Serious 
Adverse Event (eSAE) eCRF.  If the electronic data capture (EDC) system is 
unavailable to the site staff to report the Serious Adverse Event, the 
information is to be reported to Amgen via an electronic Serious Adverse 
Event (eSAE) Contingency Report Form within 24 hours of the Investigator’s 
knowledge of the event.  See Appendix G for a sample of the Serious 
Adverse Event Worksheet/electronic Serious Adverse Event Contingency 
Report Form.  For EDC studies where the first notification of a Serious 
Adverse Event is reported to Amgen via the eSAE Contingency Report 
Form, the data must be entered into the EDC system when the system is 
available again. 
 
The investigator must assess whether the serious adverse event is 
possibly related to the investigational product and/or other 
protocol-required therapies.  This relationship is indicated by a “yes” or 
“no” response to the question:  Is there a reasonable possibility that the 
event may have been caused by the investigational product?  
Relatedness means that there are facts or reasons to support a 
relationship between investigational product and the event.  The 
investigator is expected to follow reported serious adverse events until 
stabilization or reversibility. 
 
New information relating to a previously reported serious adverse event must 
be submitted to Amgen.  All new information for serious adverse events must 
be sent to Amgen within 24 hours following knowledge of the new 
 
 
 

Product:  Denosumab (AMG 162) 
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Page 30 of 56 
CONFIDENTIAL 
 
 
information.  If specifically requested, the Investigator may be asked to 
provide additional follow-up information, which may include a discharge 
summary or extracts from the medical record.  Information provided about the 
serious adverse event must be consistent with that recorded on the 
applicable eCRF (eg, Adverse Event Summary eCRF). 
Section:  9.2.3.  Reporting Serious Adverse Events After the Protocol-required 
Reporting Period, (new section) 
Add: 
9.2.3 
Reporting Serious Adverse Events After the 
Protocol-required Reporting Period 
 
There is no requirement to monitor study subjects for serious adverse 
events following the protocol-required reporting period or after end of 
study.  However, these serious adverse events can be reported to 
Amgen.  In some countries (eg, European Union [EU] member states), 
investigators are required to report serious adverse events that they 
become aware of following the protocol-required reporting or after end 
of study.  If serious adverse events are reported, the investigator is to 
report them to Amgen within 24 hours following the investigator’s 
knowledge of the event. 
 
Serious adverse events reported outside of the protocol-required 
reporting period will be captured within the safety database as clinical 
trial cases for the purposes of expedited reporting. 
Section:  9.3.  Pregnancy and Lactation Reporting, Paragraphs 2 to 5 
Replace: In addition to reporting any pregnancies occurring during the study, 
Investigators should monitor for pregnancies that occur after the last dose of 
protocol-required therapies through 5 months after the end of treatment. 
 
The pregnancy should be reported to Amgen’s global Pregnancy Surveillance 
Program (PSP) within 7 business days of the site receiving notification of a 
pregnancy.  Report a pregnancy on the Pregnancy Notification Worksheet 
(Appendix F).  The Pregnancy Surveillance Program will seek to follow the 
pregnant woman throughout her pregnancy and her baby up to 12 months 
after birth. 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
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Page 31 of 56 
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With: 
In addition to reporting any pregnancies occurring during the study, 
investigators should report pregnancies that occur through 5 months after 
the last dose of protocol-required therapies. 
 
The pregnancy should be reported to Amgen Global Patient Safety within 
24 hours of the investigator’s knowledge of the event of a pregnancy.  
Report a pregnancy on the Pregnancy Notification Worksheet (Appendix F).  
Amgen Global Patient Safety will follow-up with the investigator 
regarding additional information that may be requested. 
 
If a female subject becomes pregnant during the study, the investigator 
should attempt to obtain information regarding the birth outcome and 
health of the infant.  
 
If the outcome of the pregnancy meets a criterion for immediate 
classification as a Serious Adverse Event (eg, female subject 
experiences a spontaneous abortion, stillbirth, or neonatal death or 
there is a fetal or neonatal congenital anomaly) the investigator will 
report the event as a Serious Adverse Event. 
Section:  9.3.  Pregnancy and Lactation Reporting, Paragraph 8 
Replace: Any lactation case should be reported to Amgen’s global Lactation 
Surveillance Program (LSP) within 7 business days of the site receiving 
notification. 
With: 
Any lactation case should be reported to Amgen Global Patient Safety within 
24 hours of the investigator’s knowledge of event. 
Section:  10.1.  Study Design, Paragraphs 2 to 3 
Replace: A DMC external to Amgen and external to Daiichi Sankyo Co., Ltd. will review 
safety data at regular intervals, as outlined in the DMC charter (approximately 
twice yearly; the start date will depend on subject accrual rates).  This 
external DMC will conduct two interim analyses of efficacy; the first after 
approximately 367 subjects have developed bone metastasis or died, and 
approximately 555 subjects have developed any disease recurrence or died, 
whichever comes last; and the second after approximately 551 subjects have 
developed bone metastasis or died, and approximately 833 subjects have 
developed any disease recurrence or died, whichever comes last.  To ensure 
 
 
 

Product:  Denosumab (AMG 162) 
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timely conduct of the respective interim analyses, the interim analyses may 
be conducted early, as soon as approximately 6 months after the sufficient 
event number has been reached for either BMFS or DFS in the full study 
population, even if the event number for the other endpoint has not been 
reached. 
 
The primary analysis will be conducted after approximately 735 subjects have 
developed bone metastasis or died, and approximately 1110 subjects in the 
full study population and 512 subjects in the postmenopausal subset have 
developed any disease recurrence or died, whichever comes last.  Subjects 
will remain on blinded treatment until the primary analysis is completed. 
With: 
An external DMC will monitor the study and conduct 1 interim analysis 
of efficacy.  Refer to Section 10.5 for details. 
 
The primary analysis will be conducted after all enrolled subjects have 
had the opportunity to complete 5 years of treatment from study day 1. 
Section:  10.3 Sample Size Considerations, entire section 
Replace: The sample size calculation is based on the primary endpoint, BMFS, and is 
estimated using EAST 5.2.  Estimates of the event rates for BMFS and DFS 
for the target population are based on (Colleoni et al., 2000) and on recent 
published and unpublished data, including (Francis et al., 2008; 
Martin et al., 2005) for the HER-2 negative population, (Romond et al., 2005; 
Slamon et al., 2006) for the HER-2 positive population, (Howell et al., 2005; 
Thurlimann et al., 2005) for the population receiving adjuvant hormonal 
therapy, and (Coleman et al., 2014) for the use of adjuvant zoledronic acid in 
stage II-III breast cancer.  Based on the reported event rates, and based on 
the event rate proportions for disease recurrence in the bone, the viscera, or 
death reported by (Colleoni et al., 2000) and (Coleman et al., 2014), the 
respective rates at three years of BMFS and DFS are expected to be 
approximately 89% and 83% in the control group. 
 
For BMFS, if the true hazard ratio is 0.8, 735 subjects with an event of bone 
metastasis or death among the 4,500 planned subjects, of whom about 47% 
were postmenopausal at enrollment, will provide 85% power to detect 
superiority of denosumab over placebo.  For DFS, assuming a true hazard 
ratio of 0.83, 1110 subjects in the full study population with an event of 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 33 of 56 
CONFIDENTIAL 
 
 
disease recurrence or death, including approximately 512 subjects in the 
postmenopausal subset, will provide about 80% power to detect superiority of 
denosumab over placebo.  For DFS in the postmenopausal subset, assuming 
a true hazard ratio of 0.76, approximately 512 postmenopausal subjects with 
an event of disease recurrence or death will provide about 80% power to 
detect superiority of denosumab over placebo. 
 
The study will conclude when approximately 735 subjects have developed 
bone metastasis or died, and approximately 1110 subjects in the full study 
population and 512 subjects in the postmenopausal subset have developed 
any disease recurrence or died, whichever comes last.  With 4,500 subjects, 
an enrollment period of approximately 30 months, and a loss to follow-up rate 
of 6% per year, the study is estimated to reach the primary analysis data 
cut-off date in approximately 89 months (ie,  7 years and 5 months).  The rate 
of bone metastasis or death and the rate of disease recurrence or death of 
the pooled treatment groups will be monitored.  If the rates are lower than 
expected, then the sample size may be modified, or the study duration 
prolonged. 
With: 
The sample size calculation is based on the primary endpoint, BMFS, and is 
estimated using EAST 6.4.  Estimates of the event rates for BMFS and DFS 
for the target population are based on (Colleoni et al., 2000) and on recent 
published and unpublished data, including (Francis et al., 2008; 
Martin et al., 2005) for the HER-2 negative population, (Romond et al., 2005; 
Slamon et al., 2006) for the HER-2 positive population, (Howell et al., 2005; 
Thurlimann et al., 2005) for the population receiving adjuvant hormonal 
therapy, and (Coleman et al., 2014) for the use of adjuvant zoledronic acid in 
stage II-III breast cancer.  Based on the reported event rates, the event rate 
proportions for disease recurrence in the bone, the viscera, or death reported 
by (Colleoni et al., 2000) and (Coleman et al., 2014), and considering the 
availability of some breast cancer adjuvant therapies, the BMFS rate at 
three years is expected to be approximately 90.5% in the control group.  
Disease recurrence risk after primary breast cancer treatment can vary 
over time (Cheng et al, 2012).  For DFS, assume a piece-wise 
exponential distribution with a risk of about 5.5% per year for the first 
3 years and 3.2% per year afterwards in the control group. 
 
 
 

Product:  Denosumab (AMG 162) 
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The primary analysis will be conducted after all enrolled subjects have 
had the opportunity to complete 5 years of treatment from study day 1.  
With 4,500 subjects, an enrollment period of approximately 27 months, and a 
loss to follow-up rate of 6% per year, the study is estimated to reach the 
primary analysis data cut-off date in approximately 87 months (ie, 7 years 
and 3 months).  For BMFS, if the true hazard ratio is 0.8, the power to 
detect superiority of denosumab over placebo in the primary analysis is 
estimated to be approximately 80%.   
Section:  10.5.  Interim Analysis and Early Stopping Guidelines, Paragraph 2 
Replace: The DMC will review safety data at regular intervals, as outlined in the DMC 
charter (approximately twice yearly; the start date will depend on subject 
accrual rates), and will conduct two interim analyses of efficacy. 
With: 
The DMC will review safety data at regular intervals, as outlined in the DMC 
charter (approximately twice yearly; the start date will depend on subject 
accrual rates), and will conduct 1 interim analysis of efficacy. 
Section:  10.5.  Interim Analysis and Early Stopping Guidelines, Paragraph 2, Bullet 1 
Replace: There are two formal interim analyses; the first after approximately 
367 subjects have developed bone metastasis or died, and approximately 
555 subjects have developed any disease recurrence or died, whichever 
occurs last; and the second after approximately 551 subjects have developed 
bone metastasis or died, and approximately 833 subjects have developed 
any disease recurrence or died, whichever occurs last.  The respective 
interim analyses may be performed as soon as approximately 6 months after 
the sufficient event number has been reached for either BMFS or DFS in the 
full study population, even if the event number for the other endpoint has not 
been reached.  The critical p-values for rejecting the null or alternative 
hypothesis, as determined by the Lan-DeMets spending function with an 
O’Brien-Fleming approach for efficacy, and the Gamma Family with 
parameter -14 for futility (BMFS only), are listed in the following table.  The 
multiplicity from testing DFS in the full study population and in the 
postmenopausal subset simultaneously will be adjusted based on a 
Hochberg procedure (Sakamaki, 2013; Ye et al., 2012).  The study could 
potentially be stopped if both BMFS and DFS in the full study population 
 
 
 

Product:  Denosumab (AMG 162) 
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CONFIDENTIAL 
 
 
cross their corresponding efficacy boundaries, or if BMFS crosses the futility 
boundary at either interim analysis.  The other secondary endpoints OS and 
DRFS will only be tested when the study is stopped or at the final analysis; 
the same Lan-DeMats spending function with an O’Brien-Fleming approach 
as for BMFS will be used to adjust for multiplicity for each of these endpoints. 
With: 
There is 1 formal interim analysis after approximately 367 subjects have 
developed bone metastasis or died, and approximately 555 subjects have 
developed any disease recurrence or died, whichever occurs last.  This 
interim analysis may be performed as soon as approximately 6 months after 
the sufficient event number has been reached for either BMFS or DFS in the 
full study population, even if the event number for the other endpoint has not 
been reached.  The critical p-values for rejecting the null or alternative 
hypothesis are listed in the following table.  The multiplicity from testing DFS 
in the full study population and in the postmenopausal subset simultaneously 
will be adjusted based on a Hochberg procedure (Sakamaki, 2013; 
Ye et al., 2012).  The study could potentially be stopped if both BMFS and 
DFS in the full study population cross their corresponding efficacy 
boundaries, or if BMFS crosses the futility boundary at the interim analysis.  
The other secondary endpoints OS and DRFS will only be tested when the 
study is stopped or at the primary analysis; the same procedure as for 
BMFS will be used to adjust for multiplicity between the interim and primary 
analysis for each of these endpoints. 
 
 
 

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Section: 10.5.  Interim Analysis and Early Stopping Guidelines, Table 2 
Replace: Decision rule (1-sided) at interim/ final analyses 
Analysis 
Reject H0 
Reject H1 
Interim Analysis 1 
BMFS: P <0.0015 
DFS in the full study population:  
P <0.0004 or 
P<0.0015 for both the full study 
population and the subset 
DFS in the subset:  
P <0.0004 or 
P<0.0015 for both the full study 
population and the subset 
P >0.9333 for BMFS  
Interim Analysis 2 
BMFS: P < 0.0092 
DFS in the full study population:  
P < 0.0038; or  
P < 0.0092 for both the full study 
population and the subset; or 
P < 0.0092 if DFS in the subset was 
rejected at IA #1  
DFS in the subset:  
P < 0.0038; or  
P < 0.0092 for both the full study 
population and the subset; or  
P < 0.0092 if DFS in the full study 
population was rejected at IA #1  
P > 0.4969 for BMFS  
Final Analysis 
BMFS: P < 0.022 
DFS in the full study population:  
P < 0.0113; or  
P < 0.022 for both the full study 
population and the subset or 
P < 0.022 if DFS in the subset was 
rejected at any IA  
DFS in the subset:  
P < 0.0113; or  
P < 0.022 for both the full study 
population and the subset; or  
P < 0.022 if DFS in the full study 
population was rejected at any IA  
 
 
 
 

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With: 
Table 2.  Decision Rule (1-sided) at Interim/Primary Analyses 
Analysis 
Reject H0 
Reject H1 
Interim Analysis 
BMFS: P <0.0015 
DFS in the full study population:  
P <0.0004 or 
P<0.0015 for both the full study 
population and the subset 
DFS in the subset:  
P <0.0004 or 
P<0.0015 for both the full study 
population and the subset 
P >0.9333 for BMFS  
 
 
 
Primary Analysisa 
BMFS: P < 0.0247 
DFS in the full study population:  
P < 0.0125; or  
P < 0.0249 for the full study population 
and P < 0.0248 for the subset 
DFS in the subset:  
P < 0.0125; or  
P < 0.0249 for the full study population 
and P < 0.0248 for the subset 
 
a Boundaries are based on the estimated number of events and will be recalculated based on the 
actual observed number of events. 
Section:  10.5.  Interim Analysis and Early Stopping Guidelines, Paragraph 2, Bullet 3 
Add: 
3.  At the primary analysis that is time-driven, the exact number of 
events for the primary and secondary endpoints are not fixed and the 
final alpha boundaries can potentially vary.  Table 2 includes the 
boundaries calculated according to the estimated total numbers of 
events.  In order to strictly control the overall type I error rate, the final 
boundaries will be updated based on the actual number of events 
achieved and the alpha levels that have been spent at the interim 
analysis (Proschan et al, 2006). 
 
 
 

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Section:  10.6.1.  General Approach/Considerations, Paragraph 1 
Replace: Amgen will set a primary analysis data cut-off date in anticipation of 
approximately 735 subjects having developed bone metastasis or died, and 
approximately 1110 subjects in the full study population and 512 subjects in 
the postmenopausal subset having developed any disease recurrence or 
died, whichever comes last.  The primary analysis will be based on the data 
from randomization through the primary analysis data cut-off date. 
With: 
Amgen will set a primary analysis data cut-off date after all enrolled 
subjects have had the opportunity to complete 5 years of treatment 
from study day 1.  The primary analysis will be based on the data from 
randomization through the primary analysis data cut-off date. 
Section:  10.6.4.  Planned Methods of Analysis Through the End of the Blinded 
Treatment Phase (entire section deleted) 
Delete: 
10.6.4 
Planned Methods of Analysis Through the End of the Blinded 
Treatment Phase 
 
If appropriate, analyses described in Section 10.6 will be performed based on 
the data from randomization through end of the blinded treatment phase.  
These analyses will be supportive and exploratory in nature 
Section:  10.6.4.  Final Analysis of Data From Long-term Follow-up (entire section) 
Replace: 10.6.5 
Analysis of Data From Follow-up 
 
Selected safety data (including adverse events, laboratory assessments) and 
efficacy data (including disease recurrence, sites of recurrence, and death) 
will be summarized for the open-label treatment phase.  Events of disease 
recurrence, sites of recurrence, and deaths during the long-term survival 
follow-up, and from randomization through long-term follow-up, will also be 
summarized. 
With: 
10.6.4 
Final Analysis of Data From Long-term Follow-up 
 
Deaths during the long-term survival follow-up, and from randomization 
through long-term follow-up, will be summarized. 
 
 
 

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Section:  13.5.  Publication Policy, Paragraph 2 and Bullet 1 
Replace: Authorship of any publications resulting from this study will be determined on 
the basis of the Uniform Requirement for Manuscripts Submitted to 
Biomedical Journals (International Committee of Medical Journal Editors, 
2005), which states: 
• 
Authorship credit should be based on (1) substantial contributions to 
conception and design, acquisition of data, or analysis and interpretation 
of data; (2) drafting the article or revising it critically for important 
intellectual content; (3) final approval of the version to be published.  
Authors should meet conditions 1, 2, and 3. 
With: 
Authorship of any publications resulting from this study will be determined on 
the basis of the Recommendations for the Conduct, Reporting, Editing, 
and Publication of Scholarly Work in Medical Journals (International 
Committee of Medical Journal Editors 2013, updated 2014), which states: 
• 
Authorship credit should be based on (1) substantial contributions to 
conception and design, acquisition of data, or analysis and interpretation 
of data; (2) drafting the article or revising it critically for important 
intellectual content; (3) final approval of the version to be published; and 
(4) agreement to be accountable for all aspects of the work in 
ensuring that questions related to the accuracy or integrity of any 
part of the work are appropriately investigated and resolved.  
Authors should meet conditions 1, 2, 3, and 4. 
Section:  14.  References 
Add: 
Cheng L, Swartz MD, Zhao H, et al.  Hazard of recurrence among women 
after primary breast cancer treatment - a 10-year follow-up using data 
from SEER medicare.  Cancer Epidemiol Biomarkers Prev.  
2012;21(5):800-809. 
Section:  14.  References 
Add: 
Proschan MA, Lan KKG, Wittes JT.  Statistical Monitoring of Clinical 
Trials:  A Unified Approach.  Springer, New York; 2006. 
 
 
 
 

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Section:  Appendix A.  Schedule of Assessments 
Replace: 
 
 
 
 
 

Product:  Denosumab (AMG 162) 
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With: 
 
Treatment Period - Years 3, 4, and 5 (continued) 
 
Visit 
V16 
V17 
 
V18 
V19 
V20 
V21 
V22 
 
V23 
V24 
V25 
V26 
 
EOTP 
Week 
 
156 
Q3M (± 14 days) 
208 
Q3M (± 14 days) 
260 
265 
Year 
3 
3 
3 
4 
4 
4 
4 
4 
4 
5 
5 
5 
5 
5 
6 
Study Assessments 
Physical Examination, ECOG Status 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Oral Examination 
X 
X 
X 
X 
X 
X 
Adverse Event Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Clinical Fracture / SRE Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hypercalcemia of Malignancy Collection 
X 
Breast Cancer Therapy Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PRO Questionnaires (BPI-SF, EQ-5D) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Imaging Assessments 
Skeletal Scintigraphy 
- - - - - -X - - - - 
.- - - - - - X- - - -  
- - - - - -X - - - - - - X 
Mammography, CT/MRI Imaging 
- - - - - -X - - - - 
.- - - - - - X- - - -  
- - - - - -X - - - - - - X 
Investigational Product Administration 
Denosumab 120 mg or Placebo 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Laboratory Assessments 
Serum Albumin, Calcium 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Other Serum Values (Mg, P) 
X 
 
 
 
X 
 
 
X 
 
 
 
X  
 
 
Vitamin D 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Denosumab Antibody Collection 
X 
X 
X 
X 
Denosumab PK Sample Collection * 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Blood Biomarker, BSAP Collection 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine Collection 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tumor Sample Collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disease Recurrence/Survival Follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Long-term Follow-up 
 
Prior to primary analysis data cut-off date 
Post-primary 
analysis data cut-off 
date 
Visit 
All subjects, first 2 
visits 
All subjects without 
bone mets 
All subjects with 
documented bone mets 
Every 6M 
Notes 
Every 3M 
Every 3M 
Every 6M 
Year 
6 
6 to 10 
6 to 10 
6 to 10 
 
Study Assessments 
Clinical Fracture / SRE Collection 
X 
X 
X 
 
 
Hypercalcemia of Malignancy 
Collection 
X 
X 
X 
 
 
Breast Cancer Therapy Collection 
X 
 
 
Concomitant Medications Collection 
X 
 
 
PRO Questionnaires (BPI-SF, EQ-
5D) 
X 
 
 
 
 
Imaging Assessments 
Skeletal Scintigraphy 
Yearly 
 
 
See Section 7.2.9 
Mammography, CT/MRI Imaging 
Yearly 
 
 
See Section 7.2.9 
Laboratory Assessments 
Blood Biomarker, BSAP Collection 
X 
X 
 
As applicable, refer to 
Section 7.2.10.1 
Tumor Sample Collection 
X 
X 
 
As applicable, refer to 
Section 7.2.10.3 
Follow-up 
Disease Recurrence 
X 
X 
 
 
 
Survival 
X 
X 
X 
X 
 
 
 
 
 

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Section:  Appendix A.  Schedule of Assessments 
Delete: 
OL1.  Open-Label Treatment Phase Schedule of Assessments – Years 1, 2, and 3 
 
Visit 
V1 
V2 
V3 
V4 
V5 
V6 
V7 
V8 
V9 
V10 V11 
V12 V13 
Week 
Q4W (+ 7 days) 
Year 
1 
1 
1 
1 
1 
1 
1 
1 
1 
2 
2 
2 
2 
Study Assessments 
Physical Examination,ECOG Status 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Oral Examination 
X 
X 
X 
X 
Adverse Event Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Clinical Fracture I SRE Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hypercalcemia  of Malignancy Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Breast Cancer Therapy Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Investigational Product Administration 
Denosumab 120 mg 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Laboratory Assessments 
Serum Albumin,Calcium 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Other Serum Values (Mg,P) 
X 
X 
X 
X 
X 
Hematology (CBC,Differential),Vitamin D 
X 
Denosumab Antibody Collection 
X 
X 
X 
X 
Denosumab PK Sample Collection • 
X 
X 
X 
X 
X 
X 
Follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disease Recurrence/ Survival Follow-up 
 
 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 44 of 56 
CONFIDENTIAL 
 
 
OL1.  Open-Label Treatment Phase Schedule of Assessments – Years 3, 4, and 5 
Open Label Treatment Phase-  Years 3, 4, and 5 (continued) 
Follow-up 
Visit 
V16 V17 V18 V19 V20 V21 V22 V23 V24 V25 V26 
EOTP F/U 
Week 
Q3M (+ 14 days) 
Q3M (+ 14 days) 
265 
291 + 
Year 
3 
3 
4 
4 
4 
4 
4 
5 
5 
5 
5 
6 
6 to 10 
Study Assessments 
Physical Examination,ECOG Status 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Oral Examination 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
Adverse Event Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Clinical Fracture I SRE Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Hypercalcemia  of Malignancy Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Breast Cancer Therapy Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Concomitant Medications Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Investigational Product Administration 
 
 
 
 
 
 
 
 
 
 
 
 
 
Denosumab 120 mg 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Laboratory Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum Albumin,Calcium 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Other Serum Values (Mg,P) 
X 
X 
X 
X 
 
Hematology (CBC,Differential),Vitamin D 
 
X 
Denosumab Antibody Collection 
 
X 
X 
 
X 
X 
 
Denosumab PK Sample Collection • 
 
X 
 
 
 
 
 
Follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disease Recurrence/ Survival Follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 45 of 56 
CONFIDENTIAL 
 
 
Section:  Appendix A.  Schedule of Assessments, Legend 
Delete: 
* at selected sites only; 6M F/U, first six months of follow-up period; CBC, 
complete blood cell count; EOTP, End of Treatment Phase Visit; F/U, 
Follow-up; Mg, magnesium; P, phosphorus; PRO, patient-reported outcomes; 
Q3M, every 3 months (every 12 weeks ± 14 days); Q4W, every 4 weeks 
(± 7 days); SRE, skeletal-related event; V, visit; W, week; wks, weeks. 
Section:  Appendix A.  Schedule of Assessments, Adverse Events Footnote 
Replace: Exceptions are hypercalcemia of malignancy, clinical fractures, and SREs, 
which will be followed until the End of Study (see Sections 7.2.5.1 and 7.2.6). 
With: 
Exceptions are hypercalcemia of malignancy, clinical fractures, and SREs, 
which will be followed during LTFU prior to primary analysis data cut-off 
date (see Sections 7.2.5.1 and 7.2.6). 
Section:  Appendix A.  Schedule of Assessments, Clinical Fractures / Skeletal-related 
Events Footnote 
Replace: Information about any new clinical fractures (prior to the development of bone 
metastasis) or skeletal-related events (SREs; defined as any pathologic 
fracture [vertebral or non-vertebral], radiation therapy to bone [including the 
use of radioisotopes], surgery to bone, or spinal cord compression following 
the development of bone metastasis) will be assessed and documented at 
each scheduled clinic visit and during the follow-up period.  Copies of all 
screening and on-study radiographic assessments performed to diagnose 
clinical fractures and SREs must be submitted to the central imaging vendor.  
Copies of all screening and on-study radiology, surgery, or pathology reports 
should be kept in the subject’s records regardless if corresponding 
radiographs (or equivalent) are available. See Section 7.2.6 for details. 
 
Open-Label Treatment Phase: Radiographic assessments of events incurred 
during the open label treatment phase will not be submitted to the central 
imaging vendor. 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 46 of 56 
CONFIDENTIAL 
 
 
With: 
Information about any new clinical fractures (prior to the development of bone 
metastasis) or skeletal-related events (SREs; defined as any pathologic 
fracture [vertebral or non-vertebral], radiation therapy to bone [including the 
use of radioisotopes], surgery to bone, or spinal cord compression following 
the development of bone metastasis) will be assessed and documented at 
each scheduled clinic visit and during LTFU prior to primary analysis data 
cut-off date.  Copies of all screening and on-study radiographic assessments 
performed to diagnose clinical fractures and SREs must be submitted to the 
central imaging vendor.  Copies of all screening and on-study radiology, 
surgery, or pathology reports should be kept in the subject’s records 
regardless if corresponding radiographs (or equivalent) are available. See 
Section 7.2.6 for details.  After primary analysis data cut-off date:  
Radiographic assessments of events incurred after primary analysis 
data cut-off date will not be submitted to the central imaging vendor. 
Section:  Appendix A.  Schedule of Assessments, PRO Questionnaires (BPI-SF and 
EQ-5D) Footnote 
Delete: 
Open-Label Treatment Phase: There will be no
Section:  Appendix A.  Schedule of Assessments, Imaging Assessments Footnote 
 PRO assessments during the 
open-label treatment phase. 
Add: 
Copies of all screening and on-study radiology, surgery, or pathology reports 
should be kept in the subject’s records regardless if corresponding 
radiographs (or equivalent) are available.  All scheduled imaging will cease 
after the primary analysis data cut-off date. 
Section:  Appendix A.  Schedule of Assessments, Imagine Assessments Footnote 
Delete: 
Open-Label Treatment Phase: There will be no
Section:  Appendix A.  Schedule of Assessments, Urine Collection Footnote 
 scheduled imaging 
assessments during the open-label treatment phase. 
Delete: 
Open-Label Treatment Phase: There will be no scheduled urine collection 
during the open-label treatment phase. 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 47 of 56 
CONFIDENTIAL 
 
 
Section:  Appendix A.  Schedule of Assessments, Anti-denosumab antibodies Footnote 
Replace: Serum for anti-denosumab antibody assay will be collected at baseline (prior 
to administration of the investigational products on study day 1), on study as 
outlined in the schedule of assessments, at the EOTP visit, and 
approximately 6 months (24 weeks ± 14 days) after the last investigational 
product administration. 
With: 
Serum for anti-denosumab antibody assay will be collected at baseline (prior 
to administration of the investigational products on study day 1) and on study 
as outlined in the schedule of assessments. 
Section:  Appendix A.  Schedule of Assessments, Blood Biomarkers and BSAP 
Footnote 
Delete: 
Open-Label Treatment Phase: There will be no scheduled biomarker and 
BSAP collection during the open-label treatment phase. 
Section:  Appendix A.  Schedule of Assessments, Pharmacokinetics (PK) Footnote 
Delete: 
Open-Label Treatment Phase: After subjects have been unblinded, there will 
be no scheduled collection of PK samples for subjects, who switch from 
placebo to open-label denosumab in the open-label treatment phase.  
Subjects, who switch from blinded denosumab to open-label denosumab will 
continue PK sampling per the Schedule of Assessments. 
Section:  Appendix A.  Schedule of Assessments, Tumor Samples Footnote 
Delete: 
Open-Label Treatment Phase: There will be no tumor sample collection 
during the open-label treatment phase. 
Section:  Appendix A.  Schedule of Assessments, End of Treatment Phase (EOTP) Visit 
Footnote 
Delete: 
will be completed per Schedule of Assessments (± 14 days), or at any time 
once an individual subject discontinues study participation (4 weeks 
[+ 7 days] after the last dose of investigational product).  If denosumab is not 
determined to have a positive benefit/risk profile compared with placebo, then 
all subjects will complete the EOTP visit 4 weeks (+ 7 days) after their last 
dose of investigational product. 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 48 of 56 
CONFIDENTIAL 
 
 
 
All EOTP assessments must be completed (unless done within the prior 
4 weeks), except imaging assessments, which do not need to be repeated if 
completed within the prior 6 months (ie, 24 weeks).  If denosumab is not 
determined to have a positive benefit/risk profile compared with placebo, then 
no imaging will be required at the EOTP visit. 
Section:  Appendix A.  Schedule of Assessments, Long-term Follow-up Footnote 
Replace: Follow-up 
 
Blinded Treatment Phase 
 
After completing the treatment phase of the study (60 months from study day 
1; or as specified in Section 7.1.2.3 and Section 7.1.3), subjects will be 
followed by clinic visit or telephone contact approximately monthly 
(Q4W ± 7 days) for six months to assess clinical outcomes (SREs, 
hypercalcemia of malignancy, concomitant medications, breast cancer 
therapy, patient-reported outcomes [BPI-SF, EQ-5D], disease recurrence 
status [until documented evidence of bone metastasis] and survival), 
approximately every 3 months (every 12 weeks ± 14 days) thereafter to 
assess SREs, hypercalcemia, disease recurrence status and survival (until 
documented evidence of bone metastasis), and approximately every 
6 months (± 1 month) thereafter to assess SREs, hypercalcemia, and 
survival, for up to 10 years (120 months) from the date of randomization.  
 
Imaging assessments will continue during follow-up per the Schedule of 
Assessments, until documented evidence of disease recurrence in the bone 
(per central imaging analysis or biopsy).  See Section 7.2.9 for details.  
Copies of all radiographic assessments documenting first evidence of 
disease recurrence and first evidence of disease recurrence in the bone, 
respectively, will be submitted to the central imaging vendor. 
 
One serum sample to evaluate for the presence of anti-denosumab 
antibodies will be collected approximately 6 months (24 weeks ± 14 days) 
after the last investigational product administration.  In addition, a biomarker 
sample will be taken at the time of disease recurrence (including both first 
disease recurrence, and first disease recurrence in the bone, if applicable). 
 
Open-Label Treatment Phase 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 49 of 56 
CONFIDENTIAL 
 
 
 
After completing the open-label treatment phase of the study, subjects will be 
followed by clinic visit or telephone contact approximately every 3 months 
(every 12 weeks ± 14 days) to assess disease recurrence status, and survival 
(until documented evidence of bone metastasis), and approximately every 
6 months (± 1 month) thereafter to assess survival, for up to 10 years 
(120 months) from the date of randomization. 
 
There will be no scheduled imaging assessments during the open-label 
treatment phase. 
 
One serum sample to evaluate for the presence of anti-denosumab 
antibodies will be collected approximately 6 months (24 weeks ± 14 days) 
after the last investigational product administration.  In addition, biomarker 
samples will be taken at the time of disease recurrence (including both first 
disease recurrence, and first disease recurrence in the bone, if applicable). 
 
Follow-up if Positive Benefit/Risk is Not Determined 
 
If denosumab is not determined to have a positive benefit/risk profile 
compared with placebo, then all subjects will complete the EOTP visit and 
enter follow-up for survival (approximately every 6 months for up to 10 years 
[120 months] from the date of randomization).  
 
One serum sample to evaluate for the presence of anti-denosumab 
antibodies will be collected approximately 6 months (24 weeks ± 14 days) 
after the last investigational product administration. 
 
There will be no scheduled imaging assessments, and no other scheduled 
procedures. 
With: 
Long-term Follow-up: 
 
After completing the treatment phase of the study (60 months from study 
day 1; or as specified in Section 7.1.2.3 and Section 7.1.3), subjects will be 
enter LTFU for approximately 5 years (total study duration for an 
individual subject is up to 10 years from the date of randomization).  
The study requirements during LTFU are determined by the primary 
analysis data cut-off date, refer to Section 7.1.4.1 for assessments prior 
to primary analysis data cut-off date and Section 7.1.4.2 for 
assessments required after primary analysis data cut-off date. 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 50 of 56 
CONFIDENTIAL 
 
 
Section:  Appendix F.  Pregnancy Notification Worksheet 
Replace: 
 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 51 of 56 
CONFIDENTIAL 
 
 
With: 
 
 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 52 of 56 
CONFIDENTIAL 
 
 
Section:  Appendix G.  Serious Adverse Event Worksheet/Electronic Serious Adverse 
Event Contingency Report Form 
Delete: 
 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 53 of 56 
CONFIDENTIAL 
 
 
 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 54 of 56 
CONFIDENTIAL 
 
 
Section:  Appendix K.  Lactation Notification Worksheet 
Replace: 
 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 55 of 56 
CONFIDENTIAL 
 
 
With: 
 
 
 
 

Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  17 October 2016 
Page 56 of 56 
CONFIDENTIAL 
 
 
REFERENCES 
Cheng L, Swartz MD, Zhao H, et al.  Hazard of recurrence among women after primary 
breast cancer treatment - a 10-year follow-up using data from SEER-medicare.  Cancer 
Epidemiol Biomarkers Prev.  2012;21(5):800-809. 
Demicheli R, Abbattista A, Miceli R, Valagussa P, Bonadonna G.  Time distribution of 
the recurrence risk for breast cancer patients undergoing mastectomy:  further support 
about the concept of tumor dormancy.  Breast Cancer Res Treat.  1996;41(2):177-185.  
 
 
 

 
 
 
Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  18 March 2015 
Page 1 of 31 
CONFIDENTIAL 
 
 
Amendment # 3 
Protocol Title:  A Randomized, Double-Blind, Placebo-Controlled, Multi-Center 
Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage 
Breast Cancer at High Risk of Recurrence (D-CARE) 
 
Amgen Protocol Number (Denosumab) 20060359 
IND # 9838 
EudraCT number 2009-011299-32 
 
Amendment Date: 
18 March 2015 
 
Rationale: 
The main purpose of this protocol amendment is to add disease-free survival (DFS) in 
the postmenopausal subset as a secondary endpoint based on recently published data 
supporting an enhanced treatment effect of adjuvant bisphosphonates in 
postmenopausal subjects with early breast cancer.  
Additional changes to the study protocol are summarized below: 
 
A summary of recent literature was included in the background section to support 
adding DFS in postmenopausal women as a secondary endpoint. 
 
The hazard ratio of denosumab compared with placebo was added for the 
postmenopausal subset. 
 
Pathological variables in tumor tissue from neoadjuvant subjects after surgery 
was added as an exploratory objective, as a large proportion of the enrolled 
subjects are neoadjuvant, where pathologic evaluation after surgery is of 
importance. 
 
The numbers of subjects with events (any disease recurrence or died, whichever 
comes last) required for the interim and final analyses was updated to account 
for event rates. 
 
The period of time for which subjects must not become pregnant or breastfeed 
following the end of treatment was changed from 7 months to 5 months, in 
accordance with Investigator’s Brochure and Informed Consent Form updates.   
 
Clarification was made in the language describing study duration for individual 
participants, frequency of follow-up visits, and visit windows, to facilitate study 
conduct. 

 
 
 
Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 
Date:  18 March 2015 
Page 2 of 31 
CONFIDENTIAL 
 
 
 
The duration of the study was changed based on the change in the 
expected/projected time to primary analysis. 
 
Section 9.1.3 was updated to also include atypical femoral fracture along with 
osteonecrosis of the jaw as adverse events of interest which should undergo 
adjudication by an independent panel of experts.   
 
Covariates which may be explored in relation to the primary and secondary 
efficacy endpoints were updated, and primary tumor size and lymph node status 
were added to the list of covariates, as these are important prognostic factors.  
 
The expected event rates at 3 years for bone metastasis-free survival (BMFS) 
and DFS were updated. 
 
The Key Sponsor Contact (Global) information was updated 
 
Minor editorial changes or clarifications were made throughout the protocol for 
consistency between sections, to facilitate study conduct, or to correct 
typographical errors. 

 
 
 
Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 (D-CARE) – Amendment 2 
Date:  15 August 2012 
Page 116 of 142 
 
Amendment 2 
Protocol Title:  A Randomized, Double-Blind, Placebo-Controlled, Multi-Center 
Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage 
Breast Cancer at High Risk of Recurrence (D-CARE) 
Denosumab (AMG 162) 
 
Amgen Protocol Number (Denosumab) 20060359  
IND # 9838 
 
EudraCT number 2009-011299-32 
 
Amendment Date: 
15 August 2012 
Rationale: 
The purpose of this amendment is to extend the collection of skeletal related event 
(SRE) information through the long-term follow-up.  Objectives and endpoints for SREs 
and bone metastasis were also modified. 
Additional changes to the study are summarized below: 
 
The fasting requirement has been removed from the urine collection for uNTx 
 
The reporting timeframe for Serious Adverse Events (SAE) has been changed from 
1 day to 24 hours 
 
The SAE reporting section has been updated to reflect the use of electronic SAE 
reporting 
 
Pregnancy and Lactation Surveillance Programs have been added to section 9 
 
Typographic and formatting errors, redundancies, and inconsistencies were 
corrected. 

 
 
 
Product:  Denosumab (AMG 162) 
Protocol Number:  20060359 (D-CARE) – Amendment 1 
Date:  05 May 2011 
Page 112 of 174 
 
Amendment 1 
Protocol Title:  A Randomized, Double-Blind, Placebo-Controlled, Multi-Center 
Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage 
Breast Cancer at High Risk of Recurrence (D-CARE) 
Denosumab (AMG 162) 
 
Amgen Protocol Number (Denosumab) 20060359  
IND # 9838 
 
EudraCT number 2009-011299-32 
 
Amendment Date: 
05 May 2011 
 
Rationale: 
The purpose of this amendment is to increase the window for screening imaging 
assessments to document disease extent from 12 weeks to 24 weeks.  This increase in 
the screening window will allow subjects additional time to complete all screening 
imaging assessments required for participation in the study.   
Additionally, in consideration of the length of time anticipated to reach the primary 
analysis date, a second formal interim analysis is being added. 
The amount of time expected to reach the primary analysis data cut-off date has been 
modified from 75 months to 77 months resulting in a change in the overall event rate 
from approximately 730 subjects to 735 subjects who have developed bone metastasis 
or died, and approximately 910 subjects to 922 subjects who have developed any 
disease recurrence or died, whichever comes last. 
Additional changes to the study are summarized below: 
• 
The number of centers is being increased from 400 to 500 sites globally 
• 
Breast density measurements have been included as an exploratory outcome 
(objective and endpoint) for the study. These assessments will be performed by the 
central imaging laboratory based on protocol-specified annual mammograms. No 
additional imaging will be required. 
• 
Certain study-related definitions have been clarified including a change to the end of 
study from the end of the treatment phase to the last assessment by the last subject.  
This change in definition does not affect the overall timing or conduct of the study.  
• 
Appendix C from the original protocol has been removed and replaced with an 
Investigational Product Instruction Manual.  Other appendices have been adjusted to 
accommodate this change. 
• 
Typographic and formatting errors, redundancies, and inconsistencies were 
corrected.