Phase 3Recruiting
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer
- Sponsor
- Merck Sharp & Dohme LLC (Industry)
- Enrolment
- 2,400 planned
- Conditions
- Breast Neoplasms; Triple Negative Breast Neoplasms; HR Low-Positive/HER2-Negative Breast Neoplasms
- Interventions
- Sacituzumab tirumotecan; Pembrolizumab; Rescue Medication; Carboplatin; Paclitaxel; Doxorubicin; Epirubicin; Cyclophosphamide; Capecitabine; Olaparib
- Ages
- adults, older adults
- Registry
- NCT06966700
From the registry
Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy *…
Primary outcomes
- Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery
- Event-Free Survival (EFS)