A Multicenter, Open-Label, Randomized, Phase III Study Comparing UTD2 Combined With Capecitabine to Capecitabine Monotherapy as Adjuvant Therapy for Triple-Negative Breast Cancer Patients Who Did Not Achieve Pathological Complete Response
Phase: PHASE3
Conditions: Breast Cancer, TNBC
Sponsor: Fudan University

A Multicenter, Open-Label, Randomized, Controlled Phase III Clinical
Study Comparing UTD2 Combined with Capecitabine to Capecitabine
Monotherapy as Adjuvant Therapy for Triple-Negative Early Breast
Cancer Patients Who Did Not Achieve Pathological Complete Response
After Neoadjuvant Therapy
May 18, 2025

Sponsor
Fudan University Shanghai Cancer Center
Investigational
Product
Utidelone Capsules (UTD2)
Study ID
BG02-T2401
Study Title
A Multicenter, Open-Label, Randomized, Controlled Phase III Clinical
Study Comparing UTD2 Combined with Capecitabine to Capecitabine
Monotherapy as Adjuvant Therapy for Triple-Negative Early Breast Cancer
Patients Who Did Not Achieve Pathological Complete Response After
Neoadjuvant Therapy
Phase
Phase III
Phase III
Prof. Zhi-Min Shao
Number of
Sites
Approximately 39 centers
Study
Population
Triple-negative early breast cancer patients who did not achieve pCR after
neoadjuvant therapy
Study
Objectives
Primary Objective To evaluate the 3-year invasive disease-free survival
(IDFS) rate of UTD2 combined with capecitabine versus capecitabine
monotherapy in adjuvant therapy for triple-negative early breast cancer
patients who did not achieve pCR after neoadjuvant therapy.
Secondary Objectives - Compare IDFS rates (3-year and 5-year), overall
survival (OS) rates (3-year and 5-year), and safety profiles between the two
arms.
Exploratory Objectives - Identify predictive/prognostic biomarkers using
tumor/adjacent tissues, blood, and stool samples.
- Investigate molecular features associated with treatment response and
tumor biology.
Endpoints
Primary Endpoint
3-year IDFS rate
Secondary Endpoints 5-year IDFS rate, 3-year OS rate, 5-year OS rate,
safety analysis (CTCAE v5.0)
Translational Endpoints Biomarker discovery and correlation with
disease status/treatment response.

Study Design
Design: Multicenter, open-label, randomized, controlled, superiority Phase
III trial.
Sample Size: 440 patients (1:1 randomization: 220 in UTD2 + capecitabine
arm; 220 in capecitabine monotherapy arm).
Stratification Factor: Postoperative pathological lymph node status (negative
vs. positive).
Treatment Regimens:
Experimental Arm:
UTD2: 50 mg/m²/day orally on Days 1–5, repeated every 21 days for 2
years.
Capecitabine: 1000 mg/m² orally twice daily on Days 1–14, repeated every
21 days for 8 cycles.
Control Arm:
Capecitabine: Same dose and schedule as above.
Follow-up: Imaging every 6 months to assess disease recurrence.
Inclusion
Criteria
1.Informed Consent and Compliance
The patient has fully understood this study and voluntarily signed the
informed consent form, demonstrating the ability and willingness to comply
with the study protocol-defined visits, treatment plans, laboratory tests, and
other study procedures.
2.Age and Gender
Female patients aged 18 to 70 years old (inclusive) on the day of signing the
informed consent.
3.Prior Neoadjuvant Chemotherapy without pCR
Received prior neoadjuvant chemotherapy containing anthracycline or taxane
agents without achieving pathological complete response (pCR).
Neoadjuvant chemotherapy requirement: At least 4 completed cycles.
Non-pCR definition: Residual invasive carcinoma confirmed by pathology
after primary tumor resection.
4.Surgical Resection
Underwent complete surgical resection (R0) with pathologically confirmed
negative margins.
5.Triple-Negative Breast Cancer Confirmation

Post-resection tumor tissue confirmed as ER-negative, PR-negative, and
HER2-negative breast cancer by immunohistochemistry (IHC):
ER-negative: <1% expression by IHC.
PR-negative: <1% expression by IHC.
HER2-negative: IHC score of 0 or 1+, or 2+ with negative in situ
hybridization (ISH) results.
6.Postoperative Treatment
No prior systemic anticancer therapy (excluding radiotherapy) after breast
cancer surgery.
7.Performance Status
ECOG performance status of 0 to 1.
8.Hematological Criteria (within 1 week prior to enrollment)
Blood tests meet the following criteria (CTCAE v5.0 ≤Grade 1, based on
institutional laboratory standards):
White blood cell (WBC) count ≥3.0 × 10^9/L.
Absolute neutrophil count (ANC) ≥1.5 × 10^9/L.
Platelet (PLT) count ≥100 × 10^9/L.
Hemoglobin ≥9.0 g/dL.
No administration of recombinant human granulocyte colony-stimulating
factor (rhG-CSF), blood products, or erythropoietin (EPO) within 14 days
prior to enrollment.
9.Biochemical Criteria (within 1 week prior to enrollment)
Normal blood biochemistry (CTCAE v5.0 ≤Grade 1, based on institutional
laboratory standards):
Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN).
Alanine aminotransferase (ALT) ≤1.5 × ULN.
Aspartate aminotransferase (AST) ≤1.5 × ULN.
Alkaline phosphatase (ALP) ≤2.5 × ULN.
Creatinine clearance (Ccr) ≥50 mL/min.
Contraception Requirements
Fertile patients must agree to use highly effective contraception (hormonal,
barrier methods, or abstinence) with their partners during the trial and for at
least 6 months after the last dose. Premenopausal female patients must have a

negative blood or urine pregnancy test before enrollment.
Exclusion
Criteria
1.Stage IV metastatic breast cancer.
2.Bilateral breast cancer.
3.History of other malignancies within the past 5 years, except for cured
basal cell carcinoma of the skin, cervical carcinoma in situ, or papillary
thyroid carcinoma.
4.Radiotherapy within 2 weeks prior to the first dose of the study drug.
5.Surgery within 2 weeks prior to the first dose of the study drug.
6.Prior treatment with utidelone or capecitabine, known hypersensitivity to
utidelone,
capecitabine,
or
fluoropyrimidines,
or
confirmed
dihydropyrimidine dehydrogenase (DPD) deficiency.
7.Prior adverse reactions to anticancer therapy have not recovered to CTCAE
v5.0 Grade ≤1 (excluding toxicities deemed non-risky by the investigator,
such as alopecia).
8.Gastrointestinal
disorders
(e.g.,
esophageal
obstruction,
pyloric
obstruction, intestinal obstruction), post-gastrointestinal resection, or other
factors causing dysphagia that may interfere with oral drug absorption.
9.Severe
comorbidities,
including
significant
cardiac/cerebrovascular
disease, uncontrolled diabetes/hypertension, active infections, or active
peptic ulcer.
10.Active hepatitis B virus (HBV) infection.
11.History
of
immunodeficiency
(e.g.,
HIV-positive
status,
congenital/acquired immunodeficiency disorders) or organ transplantation.
12.Psychiatric disorders or poor compliance.
13.Pregnancy (positive pregnancy test) or lactation.
14.Concurrent participation in another interventional clinical study or
receiving other investigational therapies.
15.Concomitant use of potent CYP3A4 inhibitors/inducers or QT-prolonging
drugs within 14 days prior to the first dose or during the study.
16.Other conditions deemed unsuitable for study participation by the
investigator.
Treatment
Regimen
Experimental Group
Utidelone Capsules (UTD2):

Dosage: 50 mg/m²/day, administered orally once daily on Days 1–5.
Cycle: 21 days per treatment cycle, for a total duration of 2 years.
Capecitabine:
Dosage: 1000 mg/m², administered orally twice daily on Days 1–14.
Cycle: 21 days per treatment cycle, for a total of 8 cycles.
Treatment Discontinuation Criteria:
Study treatment will be terminated if disease recurrence or intolerable
adverse events (AEs) occur during the treatment period.
Control Group
Capecitabine:
Dosage: 1000 mg/m², administered orally twice daily on Days 1–14.
Cycle: 21 days per treatment cycle, for a total of 8 cycles.
Treatment Discontinuation Criteria:
Study treatment will be terminated if disease recurrence or intolerable
adverse events (AEs) occur during the treatment period.
Planned
Enrollment
A total of 646 subjects will be enrolled, with 323 in the experimental group
and 323 in the control group.
Statistical
Analysis
Analysis Populations
Full Analysis Set (FAS): Defined as all randomized subjects who meet the
eligibility criteria based on the Intent-to-Treat (ITT) principle.
Per Protocol Set (PPS): A subset of the FAS, excluding subjects with major
protocol deviations that significantly impact the results.
Safety Set (SS): Includes all randomized subjects who received at least one
dose of the study drug. Subjects in the SS are analyzed according to the
actual treatment received.
Sample Size Estimation
This study is a parallel-controlled superiority trial with the primary endpoint
being the investigator-assessed 3-year invasive disease-free survival (IDFS)
rate. Subjects are randomized 1:1 to the experimental and control groups.
Assuming a 3-year IDFS rate of 72% in the control group and a hazard ratio
(HR) of 0.6, a total of 122 IDFS events are required to achieve 80% power at
a two-sided significance level of α = 0.05. The calculated sample size is 418

subjects. Accounting for an approximate 5% dropout rate, a minimum of 440
subjects (220 per group) will be enrolled.
General Statistical Principles
Statistical analyses will be performed using SAS 9.4 or later. All statistical
tests will be two-sided, with 95% confidence intervals (CI). Continuous data
will be summarized using counts, means, standard deviations, quartiles,
minima, and maxima. Categorical data will be summarized using frequencies
(percentages).
Efficacy Analysis
The primary endpoint, 3-year IDFS rate, will be analyzed using Kaplan-
Meier survival curves with 95% CIs. The log-rank test will compare survival
distributions between groups. Stratified Cox proportional hazards models
will estimate HRs and 95% CIs, adjusting for postoperative pathological
lymph node status. Both the FAS and PPS will be analyzed for the primary
endpoint, with the FAS serving as the primary analysis set.
Overall survival (OS) will be analyzed using the same methods as IDFS.
IDFS and OS rates at different timepoints will be estimated using the
Kaplan-Meier method. Continuous variables will be summarized
descriptively, including mean, standard deviation, median, minimum, and
maximum.
Safety Analysis
Adverse events (AEs) will be coded using the Medical Dictionary for
Regulatory Activities (MedDRA) and graded per NCI CTCAE v5.0. Safety
analyses will focus on treatment-emergent AEs, treatment-related AEs, and
serious AEs (SAEs). Summary tables will report the number and percentage
of subjects experiencing each AE category.
Study
Duration
Patient enrollment is expected to take approximately 24 months, with the
total duration of the Phase III study estimated to be 60 months.