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) - Trial NCT06312176
Access comprehensive clinical trial information for NCT06312176 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme LLC and is currently Recruiting. The study focuses on Breast Neoplasms. Target enrollment is 1200 participants.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme LLC
Timeline & Enrollment
Phase 3
Apr 14, 2024
Apr 12, 2031
Primary Outcome
Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)
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 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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06312176
Non-Device Trial