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;