A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Summary
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 * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy
Timeline
- Start
- 2025-06-30
- Primary completion
- 2033-03-23
- Completion
- 2034-12-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sacituzumab Tirumotecan | Other / unclassified | 4 mg/kg | Intravenous |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Background | Carboplatin | Small molecule | 1.5 unknown | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Epirubicin | Small molecule | 90 mg/m2 | Intravenous |
| Background | Olaparib | Small molecule | 300 mg | Oral |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |