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)

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)

Trial Details

NCT ID
NCT06312176
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Sacituzumab tirumotecan
  • Pembrolizumab
  • Paclitaxel
  • Nab-paclitaxel
  • Capecitabine
  • Liposomal doxorubicin
Locations (sample)
  • Chandler, Arizona, United States|33.30616,-111.84125
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Fullerton, California, United States|33.87029,-117.92534
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Alamitos, California, United States|33.80307,-118.07256

Key Eligibility Criteria

  • Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negati…
  • Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer…
  • Is a chemotherapy candidate
  • Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization

For full eligibility, visit ClinicalTrials.gov.

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