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Sac-TMT Sequential Capecitabine Versus Capecitabine in Early-Stage High-Risk Triple-Negative Breast Cancer Without BRCA Mutations

NCT07628504 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2026-06-05

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT) sequential capecitabine versus single-agent capecitabine as adjuvant intensified therapy in patients with high-risk early-stage triple-negative breast cancer (TNBC) without BRCA mutations.

The main questions it aims to answer are:

1. Does sacituzumab tirumotecan (sac-TMT) sequential capecitabine improve survival outcomes compared with capecitabine monotherapy in this patient population?
2. What is the safety profile of sacituzumab tirumotecan (sac-TMT)-containing adjuvant therapy versus capecitabine monotherapy? Researchers will compare the sacituzumab tirumotecan (sac-TMT)-sequential-capecitabine experimental arm with the capecitabine-alone control arm to see if the experimental regimen provides superior adjuvant anti-tumor efficacy with acceptable safety.

Participants will be randomized in a 1:1 to Receive assigned study treatment as follows:

Experimental arm: Sacituzumab tirumotecan (sac-TMT) 4 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles, followed by sequential capecitabine at stratified doses; patients with prior PD-1/L1 inhibitor exposure will continue PD-1/L1 inhibitor therapy for up to 1 year Control arm: Capecitabine monotherapy at stratified doses; patients with prior PD-1/L1 inhibitor exposure will continue PD-1/L1 inhibitor therapy for up to 1 year

Conditions

  • Adjuvant Drug Therapy

Interventions

DRUG

Sacituzumab Tirumotecan (sac-TMT)

Sacituzumab Tirumotecan (sac-TMT) is administered intravenously at a dose of 4 mg/kg on Day 1 of each 3-week cycle for a total of 8 cycles.

DRUG

Capecitabine

Capecitabine is administered orally with stratified doses based on prior neoadjuvant therapy status: for patients who received neoadjuvant therapy, capecitabine is given at 1000-1250 mg/m² twice daily on a 2-week-on-1-week-off schedule for 6-8 cycles; for patients without prior neoadjuvant therapy, capecitabine is given at 650 mg/m² twice daily for 1 year.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2030-03-30
Completion
2035-03-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07628504 on ClinicalTrials.gov