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

Launched by MERCK SHARP & DOHME LLC · May 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called sacituzumab tirumotecan (or sac-TMT) for people with certain types of breast cancer, specifically high-risk, early-stage triple-negative breast cancer and hormone receptor low-positive/HER2-negative breast cancer. The researchers want to see if adding sac-TMT to standard treatments (pembrolizumab and chemotherapy) helps reduce the number of cancer cells in the tumors and lymph nodes and improves how long patients can live without the cancer coming back.

To participate in this study, individuals must have recently diagnosed, high-risk, early-stage breast cancer that has not been treated before. They need to provide a biopsy of the tumor and have a good overall health status. The trial is not yet recruiting participants, but it will be open to all genders aged 65 to 74. Those interested should note that they cannot have received any previous treatments for breast cancer or have more advanced cancer. Participants can expect to receive a combination of treatments and will be monitored closely throughout the study.

Gender

ALL

Eligibility criteria

• 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 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 epidermal growth factor 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 10 days of treatment initiation.
• • 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 randomization.
• • 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 or has current pneumonitis/interstitial lung disease.