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Phase III

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

  • Study HIC#:2000037395
  • Last Updated:11/21/2024

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.

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    Eligibility 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

    Principal Investigator

    Sub-Investigators

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