Status:
RECRUITING
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone rece...
Eligibility Criteria
Inclusion
- Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
- Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
- Is a chemotherapy candidate
- Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- Has adequate organ function
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion
- Has breast cancer amenable to treatment with curative intent
- Has experienced an early recurrence (\<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
- Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
- Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
- Active autoimmune disease that has required systemic treatment in the past 2 years
- History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
Key Trial Info
Start Date :
April 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 12 2031
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT06312176
Start Date
April 14 2024
End Date
April 12 2031
Last Update
March 13 2026
Active Locations (257)
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1
Ironwood Cancer & Research Centers ( Site 0066)
Chandler, Arizona, United States, 85224
2
Banner MD Anderson Cancer Center-Oncology ( Site 0004)
Gilbert, Arizona, United States, 85234
3
Providence Medical Foundation-Oncology ( Site 0020)
Fullerton, California, United States, 92835
4
Moores Cancer Center ( Site 0059)
La Jolla, California, United States, 92093-0698