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RECRUITINGPhase 3INTERVENTIONAL

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)

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 your organs (liver, kidneys, etc.) are working well enough based on blood tests - Human weakened immune system 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 Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body) 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Sacituzumab tirumotecan

IV infusion

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Nab-paclitaxel

IV infusion

DRUG

Capecitabine

oral tablet

DRUG

Liposomal doxorubicin

IV infusion

Locations (20)

Ironwood Cancer & Research Centers ( Site 0066)
Chandler, Arizona, United States
Banner MD Anderson Cancer Center-Oncology ( Site 0004)
Gilbert, Arizona, United States
Providence Medical Foundation-Oncology ( Site 0020)
Fullerton, California, United States
Moores Cancer Center ( Site 0059)
La Jolla, California, United States
Cancer and Blood Specialty Clinic ( Site 0001)
Los Alamitos, California, United States
University of Colorado Anschutz Medical Campus ( Site 0061)
Aurora, Colorado, United States
UCHealth Cherry Creek Medical Center ( Site 0094)
Denver, Colorado, United States
University of Colorado Health - Highlands Ranch Hospital ( Site 0095)
Highlands Ranch, Colorado, United States
Yale Cancer Center ( Site 0060)
New Haven, Connecticut, United States
Stamford Hospital ( Site 0049)
Stamford, Connecticut, United States
AdventHealth Altamonte Springs ( Site 0021)
Altamonte Springs, Florida, United States
University of Florida College of Medicine ( Site 0063)
Gainesville, Florida, United States
Orlando Health Cancer Institute ( Site 0011)
Orlando, Florida, United States
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)
Thomasville, Georgia, United States
Rush University Medical Center ( Site 0079)
Chicago, Illinois, United States
University of Chicago Medical Center ( Site 0067)
Chicago, Illinois, United States
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)
Edgewood, Kentucky, United States
Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)
Baton Rouge, Louisiana, United States
Greenebaum Comprehensive Cancer Center ( Site 0036)
Baltimore, Maryland, United States
Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028)
Baltimore, Maryland, United States