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
Female aged ≥ 18 years old.
Diagnosis of operable primary invasive breast cancer.
Negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER2), defined as follows: ER-negative is defined as <10 % positive tumor cells by immunohistochemistry (IHC); PR-negative is defined as <10 % positive tumor cells by IHC; HER2-negative is defined as IHC score of 0 or 1+, or IHC score of 2+ with negative (non-amplified) results confirmed by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH).
Non-mutated for BRCA1/2 genes.
Patients with Stage T4 disease, including those with inflammatory breast cancer;
Patients with Stage N3 disease;
Patients with positive supraclavicular or internal mammary lymph nodes;
Previous history of breast cancer;
Parallel
Sacituzumab Tirumotecan (sac-TMT)
DrugSacituzumab 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
DrugCapecitabine 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.
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.
Distant Disease-Free Survival (DDFS)
Overall survival
Adverse events (AEs)
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This trial is not recruiting at the moment. You can still explore other options:
