Study

Overview

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

Eligibility

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

Locations

United States Toll Free Number 1-800-770-4674

Nyack, New York, 10960

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary - MK-2870-010

Study Detail

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)