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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)

ClinicalTrials.gov Identifier: NCT06312176 (view full study on clinicaltrials.gov)
Condition:  Breast Neoplasms
Status:  Recruiting


Official Title: 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

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.

Study Type:
Interventional
Study Phase:
Phase 3
Estimated Enrollment:
1200
Study Start Date:
April 2024
Estimated Study Completion Date:
April 2031
Estimated Primary Completion Date:
July 2027
Ages Eligible for Study:
18 years and older
Genders Eligible for Study:
All
Accepts Healthy Volunteers:
No


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

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Canada     Study Coordinator     514-252-3400 x5370   

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