A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Recruiting now · Phase 3

Conditions studied: Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms

In brief

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

Key facts

Study ID

NCT06966700

Run by

Merck Sharp & Dohme LLC

People needed

2400

Starts

2025-06-30

Expected to finish

2034-12-29

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The main inclusion criteria include but are not limited to the following:
• Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and/or clinical assessment:
• cT1c, N1-N2
• cT2, N0-N2
• cT3, N0-N2
• cT4a-d, N0-N2
• The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
• Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).
• Demonstrates adequate organ function.

You may not qualify if…

• The main exclusion criteria include but are not limited to the following:
• Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
• Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer
• Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment.
• Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.
• Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).
• Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
• Received prior treatment with a topoisomerase I inhibitor-containing ADC.
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
• Known additional malignancy that is progressing or has required active treatment within the past 5 years.
• Uncontrolled systemic disease.
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, has current pneumonitis/interstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..

Where it is running

• Mayo Clinic Cancer Center ( Site 0034) — Phoenix, Arizona, United States (enrolling)
• University of Arizona Cancer Center ( Site 0035) — Tucson, Arizona, United States (enrolling)
• Roy and Patricia Disney Family Cancer Center ( Site 0055) — Burbank, California, United States (enrolling)
• Community Cancer Institute ( Site 0100) — Clovis, California, United States (enrolling)
• Providence Medical Foundation ( Site 0080) — Fullerton, California, United States (enrolling)
• MemorialCare Health System - Long Beach Medical Center ( Site 9556) — Long Beach, California, United States (enrolling)
• El Camino Hospital Cancer Center ( Site 0096) — Mountain View, California, United States (enrolling)
• Hoag Memorial Hospital Presbyterian ( Site 0010) — Newport Beach, California, United States (enrolling)
• Helios Clinical Research ( Site 0061) — Whittier, California, United States (enrolling)
• Intermountain Health Cancer Center Saint Joseph ( Site 0062) — Denver, Colorado, United States (enrolling)
• Rocky Mountain Cancer Centers (RMCC) ( Site 8006) — Denver, Colorado, United States (enrolling)
• Intermountain Health St. Mary's Regional Hospital ( Site 0054) — Grand Junction, Colorado, United States (enrolling)
• AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0044) — Altamonte Springs, Florida, United States (enrolling)
• Florida Cancer Specialists - South ( Site 7004) — Fort Myers, Florida, United States (enrolling)
• Bioresearch Partner ( Site 0072) — Hialeah, Florida, United States (enrolling)
• Mayo Clinic Hospital ( Site 0013) — Jacksonville, Florida, United States (enrolling)
• Florida Cancer Specialists - North ( Site 7002) — St. Petersburg, Florida, United States (enrolling)
• City of Hope Cancer Center - Atlanta ( Site 0102) — Newnan, Georgia, United States (enrolling)
• Fort Wayne Medical Oncology and Hematology ( Site 0084) — Fort Wayne, Indiana, United States (enrolling)
• Franciscan Health ( Site 0077) — Indianapolis, Indiana, United States (enrolling)
• Ochsner Clinic Foundation ( Site 0021) — New Orleans, Louisiana, United States (enrolling)
• Louisiana State University Health Sciences Shreveport ( Site 0053) — Shreveport, Louisiana, United States (enrolling)
• New England Cancer Specialists ( Site 0051) — Westbrook, Maine, United States (enrolling)
• Mercy Medical Center - Baltimore ( Site 0015) — Baltimore, Maryland, United States (enrolling)
• Banner MD Anderson Cancer Center ( Site 0066) — Gilbert, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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