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TROFUSE-010

TROFUSE-010

Open for recruitment

Trial summary

An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer

Receptor status / problem studied

  • 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

Trial details

Trial title

TROFUSE-010

Diagnosis

Condition 3

Condition 2

Type of treatment

Medical Oncology

Locations

Investigators

Principal Investigators