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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Sacituzumab tirumotecan 		Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.
  • Drug: Sacituzumab tirumotecan
    IV infusion
    Other names:
    • MK-2870
Experimental
Arm B:Pembrolizumab + Sacituzumab tirumotecan 		Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation PLUS 400 mg of pembrolizumab once every 6 weeks (Q6W) via IV infusion for up to 18 administrations (up to ~2 years).
  • Drug: Sacituzumab tirumotecan
    IV infusion
    Other names:
    • MK-2870
  • Biological: Pembrolizumab
    IV infusion
    Other names:
    • MK-3475
    • KEYTRUDA®
Active Comparator
Arm C: Treatment of Physician's Choice (TPC) 		At the physician's discretion, participants receive chemotherapy of 80 mg/m^2 of paclitaxel once every week (Q1W) via IV infusion OR 90 mg/m^2 of paclitaxel once every 4 weeks (Q4W) via IV infusion OR 100 mg/m^2 of nab-paclitaxel Q4W via IV infusion OR 1000 mg/m^2 of capecitabine every 3 weeks (Q3W) orally OR 50 mg/m^2 of liposomal doxorubicin once every 4 weeks (Q4W) via IV infusion, until progressive disease or discontinuation.
  • Drug: Paclitaxel
    IV infusion
    Other names:
    • TAXOL®
  • Drug: Nab-paclitaxel
    IV infusion
    Other names:
    • ABRAXANE®
  • Drug: Capecitabine
    oral tablet
    Other names:
    • XELODA®
  • Drug: Liposomal doxorubicin
    IV infusion
    Other names:
    • DOXIL®

Recruiting Locations

Ironwood Cancer & Research Centers ( Site 0066)
Chandler, Arizona 85224
Contact:
Study Coordinator
888-577-8839

Banner MD Anderson Cancer Center-Oncology ( Site 0004)
Gilbert, Arizona 85234
Contact:
Study Coordinator
480-256-6444

Providence Medical Foundation-Oncology ( Site 0020)
Fullerton, California 92835
Contact:
Study Coordinator
714-446-5900

Moores Cancer Center ( Site 0059)
La Jolla, California 92093-0698
Contact:
Study Coordinator
888-577-8839

Cancer and Blood Specialty Clinic ( Site 0001)
Los Alamitos, California 90720
Contact:
Study Coordinator
888-577-8839

University of Colorado Anschutz Medical Campus ( Site 0061)
Aurora, Colorado 80045
Contact:
Study Coordinator
888-577-8839

UCHealth Cherry Creek Medical Center ( Site 0094)
Denver, Colorado 80206
Contact:
Study Coordinator
720-848-1030

University of Colorado Health - Highlands Ranch Hospital ( Site 0095)
Highlands Ranch, Colorado 80129
Contact:
Study Coordinator
720-848-1030

Yale Cancer Center ( Site 0060)
New Haven, Connecticut 06510
Contact:
Study Coordinator
888-577-8839

Stamford Hospital ( Site 0049)
Stamford, Connecticut 06904
Contact:
Study Coordinator
888-577-8839

AdventHealth Altamonte Springs ( Site 0021)
Altamonte Springs, Florida 32701
Contact:
Study Coordinator
888-577-8839

University of Florida College of Medicine ( Site 0063)
Gainesville, Florida 32610
Contact:
Study Coordinator
888-577-8839

Orlando Health Cancer Institute ( Site 0011)
Orlando, Florida 32806
Contact:
Study Coordinator
888-577-8839

Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)
Thomasville, Georgia 31792
Contact:
Study Coordinator
229-584-5400

University of Chicago Medical Center ( Site 0067)
Chicago, Illinois 60637
Contact:
Study Coordinator
888-577-8839

Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)
Edgewood, Kentucky 41017
Contact:
Study Coordinator
888-577-8839

Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)
Baton Rouge, Louisiana 70817
Contact:
Study Coordinator
888-577-8839

Greenebaum Comprehensive Cancer Center ( Site 0036)
Baltimore, Maryland 21201
Contact:
Study Coordinator
410-328-6373

Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028)
Baltimore, Maryland 21202
Contact:
Study Coordinator
888-577-8839

Holy Cross Hospital ( Site 0073)
Silver Spring, Maryland 20910
Contact:
Study Coordinator
301-754-7000

Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)
Boston, Massachusetts 02215
Contact:
Study Coordinator
888-577-8839

Henry Ford Health ( Site 0002)
Detroit, Michigan 48202
Contact:
Study Coordinator
313-916-2576

Saint Luke's Cancer Institute ( Site 0027)
Kansas City, Missouri 64111
Contact:
Study Coordinator
816-932-2677

Washington University School of Medicine ( Site 0076)
Saint Louis, Missouri 63110
Contact:
Study Coordinator
314-454-8313

Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068)
New York, New York 10016
Contact:
Study Coordinator
212-731-6000

Hematology Oncology Associates of Rockland ( Site 0054)
Nyack, New York 10960
Contact:
Study Coordinator
888-577-8839

Stony Brook University-Cancer Center ( Site 0034)
Stony Brook, New York 11794
Contact:
Study Coordinator
888-577-8839

Levine Cancer Institute ( Site 0014)
Charlotte, North Carolina 28204
Contact:
Study Coordinator
980-442-2000

Zangmeister Cancer Center ( Site 7000)
Columbus, Ohio 43219
Contact:
Study Coordinator
614-383-6000

Providence Portland Medical Center ( Site 0044)
Portland, Oregon 97213
Contact:
Study Coordinator
503-215-2619

Providence St. Vincent Medical Center ( Site 0081)
Portland, Oregon 97225
Contact:
Study Coordinator
503-215-2619

Thomas Jefferson University - Clinical Research Institute ( Site 0056)
Philadelphia, Pennsylvania 19107
Contact:
Study Coordinator
215-955-8874

Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)
Dallas, Texas 75231
Contact:
Study Coordinator
214-265-2080

The Center for Cancer and Blood Disorders ( Site 0041)
Fort Worth, Texas 76104
Contact:
Study Coordinator
888-577-8839

Texas Oncology - San Antonio ( Site 8002)
San Antonio, Texas 78240
Contact:
Study Coordinator
212-241-0493

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057)
Tyler, Texas 75701
Contact:
Study Coordinator
903-595-7093

Inova Schar Cancer Institute ( Site 0025)
Fairfax, Virginia 22031
Contact:
Study Coordinator
501-650-1726

Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015)
Midlothian, Virginia 23114
Contact:
Study Coordinator
888-577-8839

VCU Health Adult Outpatient Pavillion ( Site 0070)
Richmond, Virginia 23219
Contact:
Study Coordinator
888-577-8839

Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001)
Roanoke, Virginia 24014
Contact:
Study Coordinator
540-982-0237

University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040)
Madison, Wisconsin 53792
Contact:
Study Coordinator
888-577-8839

UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0677)
San Juan, Puerto Rico 00935
Contact:
Study Coordinator
7877728300 Ext 1226

More Details

NCT ID
NCT06312176
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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