Status:
RECRUITING
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Breast Neoplasms
Triple Negative Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 * Earl...
Eligibility Criteria
Inclusion
- 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 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 treatment randomization.
- Demonstrates adequate organ function.
Exclusion
- 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.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2034
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT06966700
Start Date
June 30 2025
End Date
December 29 2034
Last Update
January 5 2026
Active Locations (169)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner MD Anderson Cancer Center ( Site 0066)
Gilbert, Arizona, United States, 85234
2
Roy and Patricia Disney Family Cancer Center ( Site 0055)
Burbank, California, United States, 91505
3
Providence Medical Foundation ( Site 0080)
Fullerton, California, United States, 92835
4
Helios Clinical Research ( Site 0061)
Whittier, California, United States, 90602