Recruiting

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

ClinicalTrials.gov IDNCT06966700

PhasePHASE3

Enrollment2400

SponsorMerck Sharp & Dohme LLC

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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

Interventions

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

Primary outcomes

Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery (Up to approximately 30 weeks)
Event-Free Survival (EFS) (Up to approximately 92 months)

Eligibility information

Inclusion Criteria: 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. Exclusion Criteria: 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..

Study locations

Banner MD Anderson Cancer Center ( Site 0066), Gilbert, Arizona 85234 United States
Mayo Clinic Cancer Center ( Site 0034), Phoenix, Arizona 85054 United States
University of Arizona Cancer Center ( Site 0035), Tucson, Arizona 85719 United States
Roy and Patricia Disney Family Cancer Center ( Site 0055), Burbank, California 91505 United States
Community Cancer Institute ( Site 0100), Clovis, California 93611 United States
Providence Medical Foundation ( Site 0080), Fullerton, California 92835 United States
MemorialCare Health System - Long Beach Medical Center ( Site 9556), Long Beach, California 90806 United States
El Camino Hospital Cancer Center ( Site 0096), Mountain View, California 94040 United States
Hoag Memorial Hospital Presbyterian ( Site 0010), Newport Beach, California 92663 United States
Helios Clinical Research ( Site 0061), Whittier, California 90602 United States

Showing 10 of 325 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.