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
Summary
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.
Arms & interventions
- DrugSacituzumab tirumotecan
IV infusion
- BiologicalPembrolizumab
IV infusion
- DrugPaclitaxel
IV infusion
- DrugNab-paclitaxel
IV infusion
- DrugCapecitabine
oral tablet
- DrugLiposomal doxorubicin
IV infusion
Outcome measures
Primary
Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Time frame: Up to ~38 months
Secondary
Overall Survival (OS)
Time frame: Up to ~77 months
Progression-Free Survival (PFS) (pembrolizumab + sacituzumab tirumotecan + versus sacituzumab tirumotecan)
Time frame: Up to ~57 months
Objective Response Rate (ORR)
Time frame: Up to ~57 months
Duration of Response (DOR)
Time frame: Up to ~57 months
Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Baseline and up to ~77 months
Change from baseline in physical functioning score, on the EORTC QLQ-C30
Time frame: Baseline and up to ~77 months
Change from baseline in emotional functioning score, on the EORTC QLQ-C30
Time frame: Baseline and up to ~77 months
Change from baseline in fatigue score, on the EORTC QLQ-C30
Time frame: Baseline and up to ~77 months
Change from baseline in diarrhea score, on the EORTC QLQ-C30
Time frame: Baseline and up to ~77 months
Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30
Time frame: Up to ~77 months
TTD in physical functioning score, on the EORTC QLQ-C30
Time frame: Up to ~77 months
TTD in emotional functioning score, on the EORTC QLQ-C30
Time frame: Up to ~77 months
TTD in fatigue score, on the EORTC QLQ-C30
Time frame: Up to ~77 months
TTD in diarrhea score, on the EORTC QLQ-C30
Time frame: Up to ~77 months
Number of participants who experience one or more adverse events (AEs)
Time frame: Up to ~77 months
Number of participants who discontinue study treatment due to an AE
Time frame: Up to ~77 months
Eligibility criteria
Study locations (46)
Ironwood Cancer & Research Centers ( Site 0066)
Chandler, Arizona, 85224
Banner MD Anderson Cancer Center-Oncology ( Site 0004)
Gilbert, Arizona, 85234
Providence Medical Foundation-Oncology ( Site 0020)
Fullerton, California, 92835
Moores Cancer Center ( Site 0059)
La Jolla, California, 92093-0698
Cancer and Blood Specialty Clinic ( Site 0001)
Los Alamitos, California, 90720
University of Colorado Anschutz Medical Campus ( Site 0061)
Aurora, Colorado, 80045
UCHealth Cherry Creek Medical Center ( Site 0094)
Denver, Colorado, 80206
University of Colorado Health - Highlands Ranch Hospital ( Site 0095)
Highlands Ranch, Colorado, 80129
Yale Cancer Center ( Site 0060)
New Haven, Connecticut, 06510
Stamford Hospital ( Site 0049)
Stamford, Connecticut, 06902
AdventHealth Altamonte Springs ( Site 0021)
Altamonte Springs, Florida, 32701
University of Florida College of Medicine ( Site 0063)
Gainesville, Florida, 32610
Orlando Health Cancer Institute ( Site 0011)
Orlando, Florida, 32806
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)
Thomasville, Georgia, 31792
Rush University Medical Center ( Site 0079)
Chicago, Illinois, 60607
University of Chicago Medical Center ( Site 0067)
Chicago, Illinois, 60637
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)
Edgewood, Kentucky, 41017
Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)
Baton Rouge, Louisiana, 70817
Greenebaum Comprehensive Cancer Center ( Site 0036)
Baltimore, Maryland, 21201
Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028)
Baltimore, Maryland, 21202
Holy Cross Hospital ( Site 0073)
Silver Spring, Maryland, 20910
Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)
Boston, Massachusetts, 02215
Henry Ford Health ( Site 0002)
Detroit, Michigan, 48202
Saint Luke's Cancer Institute ( Site 0027)
Kansas City, Missouri, 64111
Washington University School of Medicine ( Site 0076)
St Louis, Missouri, 63110
NYU Langone Health - Brooklyn ( Site 0089)
Brooklyn, New York, 11220
NYU Langone Hospital - Long Island ( Site 0090)
Mineola, New York, 11501
Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068)
New York, New York, 10016
Hematology Oncology Associates of Rockland ( Site 0054)
Nyack, New York, 10960
Stony Brook University-Cancer Center ( Site 0034)
Stony Brook, New York, 11794
Levine Cancer Institute ( Site 0014)
Charlotte, North Carolina, 28204
Zangmeister Cancer Center ( Site 7000)
Columbus, Ohio, 43219
Providence Portland Medical Center ( Site 0044)
Portland, Oregon, 97213
Providence St. Vincent Medical Center ( Site 0081)
Portland, Oregon, 97225
Thomas Jefferson University - Clinical Research Institute ( Site 0056)
Philadelphia, Pennsylvania, 19107
Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)
Dallas, Texas, 75231
Parkland Health and Hospital System ( Site 0069)
Dallas, Texas, 75235
UT Southwestern Medical Center ( Site 0050)
Dallas, Texas, 75390
The Center for Cancer and Blood Disorders ( Site 0041)
Fort Worth, Texas, 76104
Texas Oncology - San Antonio ( Site 8002)
San Antonio, Texas, 78240
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057)
Tyler, Texas, 75701
Inova Schar Cancer Institute ( Site 0025)
Fairfax, Virginia, 22031
Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015)
Midlothian, Virginia, 23114
VCU Health Adult Outpatient Pavillion ( Site 0070)
Richmond, Virginia, 23219
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001)
Roanoke, Virginia, 24014
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040)
Madison, Wisconsin, 53792