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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
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.
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.
Fudan University Shanghai Cancer Center, Shanghai, Shanghai 200032
Shanghai, Shanghai Municipality, China
Disease-Free Survival (DFS)
Disease-Free Survival (DFS), defined as the time from randomization to disease recurrence or death from any cause, whichever occurs first.
Time frame: 3-year DFS
Distant Disease-Free Survival (DDFS)
Time frame: from the first dose administration to the first occurrence of distant metastasis or death due to breast cancer, whichever occurs first.up to 5 years
Overall survival
Time frame: from the first dose administration to death from any cause of the participant.up to 5 years
Adverse events (AEs)
Time frame: 90 days after the last administration of study treatment
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