NCT06966700

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,400 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• HR Low-Positive/HER2-Negative Breast Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Sacituzumab tirumotecan	IV infusion
BIOLOGICAL	Pembrolizumab	IV infusion
DRUG	Rescue Medication	Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).
DRUG	Carboplatin	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Doxorubicin	IV infusion
DRUG	Epirubicin	IV infusion
DRUG	Cyclophosphamide	IV infusion
DRUG	Capecitabine	Oral tablet
DRUG	Olaparib	Oral tablet

Timeline

• Start date: 2025-06-30
• Primary completion: 2033-03-23
• Completion: 2034-12-29
• First posted: 2025-05-13
• Last updated: 2026-04-17

Locations

268 sites across 37 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study