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)

Description

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.

Conditions

Breast Neoplasms

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Study Overview

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Study Details

Study overview

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.

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

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)

Condition
Breast Neoplasms
Intervention / Treatment

-

Contacts and Locations

Chandler

Ironwood Cancer & Research Centers ( Site 0066), Chandler, Arizona, United States, 85224

Fullerton

Providence Medical Foundation-Oncology ( Site 0020), Fullerton, California, United States, 92835

New Haven

Yale Cancer Center ( Site 0060), New Haven, Connecticut, United States, 06510

Altamonte Springs

AdventHealth Altamonte Springs ( Site 0021), Altamonte Springs, Florida, United States, 32701

Orlando

Orlando Health Cancer Institute ( Site 0011), Orlando, Florida, United States, 32806

Thomasville

Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032), Thomasville, Georgia, United States, 31792

Baton Rouge

Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042), Baton Rouge, Louisiana, United States, 70817

Baltimore

Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028), Baltimore, Maryland, United States, 21202

Nyack

Hematology Oncology Associates of Rockland ( Site 0054), Nyack, New York, United States, 10960

Stony Brook

Stony Brook University-Cancer Center ( Site 0034), Stony Brook, New York, United States, 11794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2031-04-12