Sac-TMT Sequential Capecitabine Versus Capecitabine in Early-Stage High-Risk Triple-Negative Brea… (NCT07628504) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Sac-TMT Sequential Capecitabine Versus Capecitabine in Early-Stage High-Risk Triple-Negative Breast Cancer Without BRCA Mutations
China420 participantsStarted 2026-05-18
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 must satisfy any one of the following conditions:
. Baseline clinical lymph node-positive (cLN+) or pathological lymph node-positive (pN+) status with non-pathological complete response (non-pCR), who have completed adequate neoadjuvant therapy (at least 6 cycles of chemotherapy containing anthracycline and/or taxane, with or without PD-1 inhibitor immunotherapy).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Pathological lymph node-positive (pN+) status without prior neoadjuvant therapy, who have undergone adequate surgery, adjuvant chemotherapy (at least 6 cycles of taxane- and/or anthracycline-containing regimen with or without carboplatin), and adjuvant radiotherapy (if applicable).
. No evidence of distant metastasis shown by imaging examinations performed within 3 months prior to randomization.
Exclusion criteria
. 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;
. Significant cardiovascular diseases such as baseline left ventricular ejection fraction (LVEF) \< 50% assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan at screening, or New York Heart Association (NYHA) Class III or IV cardiomyopathy;
. Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors;
. History of other malignant neoplasms within the past 5 years, excluding cured carcinoma in situ of the cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma;
. Known hypersensitivity to study drugs and their components, history of immunodeficiency, or history of organ transplantation;