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)
Breast NeoplasmsThe 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 receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.
The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Study Location
Jewish General Hospital ( Site 0303)
Jewish General Hospital ( Site 0303)Montreal, Quebec
Canada
Contact Study Team
Study Coordinator
51434082224210CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301)
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301)Montreal, Quebec
Canada
Contact Study Team
Study Coordinator
514 252-3400 EXT 5853Princess Margaret Cancer Centre ( Site 0310)
Princess Margaret Cancer Centre ( Site 0310)Toronto, Ontario
Canada
Contact Study Team
Study Coordinator
1-888-577-8839Southlake Regional Health Centre ( Site 0311)
Southlake Regional Health Centre ( Site 0311)Newmarket, Ontario
Canada
Contact Study Team
Study Coordinator
1-888-577-8839Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski (
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski (Rimouski, Quebec
Canada
Contact Study Team
Study Coordinator
1-888-577-8839- Study Sponsored By
- Merck Sharp & Dohme LLC
- Participants Required
- More Information
- Study ID:
NCT06312176