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A Phase 3 Randomized Study of Sacituzumab Tirumotecan Plus Pembrolizumab and Chemotherapy Versus Pembrolizumab and Chemotherapy for High-Risk, Early-Stage Triple-Negative or HR-Low PositiveHER2-Negative Breast Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
2400
Participants Needed
294
Research Sites
92 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating new treatments for high-risk, early-stage breast cancers that are either triple-negative or hormone receptor-low positive and HER2-negative. These types of breast cancer have limited amounts of certain proteins that affect growth, making them challenging to treat. This Phase 3 trial aims to compare the effects of adding sacituzumab tirumotecan, a targeted therapy, to pembrolizumab and chemotherapy against pembrolizumab with chemotherapy alone in controlling cancer growth and spread. Participants are randomly assigned to one of two treatment groups. One group receives sacituzumab tirumotecan intravenously every two weeks along with pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab combined with carboplatin and paclitaxel for another 12 weeks. After this, surgery and optional radiation therapy occur, followed by pembrolizumab infusions for up to about 28 weeks. Additional treatments such as olaparib, capecitabine, or doxorubicin with cyclophosphamide may be given if cancer remains. The other group receives chemotherapy drugs carboplatin, paclitaxel, cyclophosphamide, and doxorubicin or epirubicin alongside pembrolizumab during similar time frames, followed by surgery, radiation, and pembrolizumab maintenance with possible additional treatments. Throughout the study, participants undergo assessments including surgery to remove tumors, imaging, and laboratory tests. Researchers measure cancer cell presence after surgery and monitor how long participants live without cancer progression or recurrence, as well as overall survival. Quality of life and side effects are tracked using questionnaires over several years. Safety is monitored by recording adverse events and treatment discontinuations. The study may last up to around 115 months for long-term follow-up.
CONDITIONS
Brief Title
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Previously untreated high-risk, early-stage, non-metastatic breast cancer
- Breast cancer confirmed as triple-negative or hormone receptor-low positive and HER2-negative
- Core needle biopsy provided from primary breast tumor at screening
- ECOG performance status of 0 or 1 within 28 days before first treatment
- Adequate organ function as determined by investigators
You will not qualify if you...
- Metastatic (Stage IV) breast cancer or clinical node stage 3 involvement
- Prior treatment including radiation, systemic therapy, or definitive surgery for current breast cancer
- Prior excisional biopsy of primary tumor or lymph node dissection before study treatment
- Systemic anticancer therapy including investigational agents within 4 weeks before first treatment
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or T-cell receptor targeting agents
- Prior treatment with TROP2-targeted or topoisomerase I inhibitor antibody-drug conjugates
- Live or live-attenuated vaccine within 30 days before first dose
- Active malignancy requiring treatment within past 5 years
- Uncontrolled systemic disease
- History or presence of pneumonitis or interstitial lung disease that required steroids or cannot be ruled out at screening
Research Team
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