A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)
Summary
Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.
Arms & interventions
- BiologicalSacituzumab tirumotecan
IV Infusion
- BiologicalPembrolizumab
IV Infusion
- DrugRescue Medication
Participants receive the following pre-medications before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. Participants are also recommended to receive prophylactic steroid mouthwash (dexamethasone or equivalent).
- DrugPaclitaxel
IV Infusion
- DrugNab-paclitaxel
IV Infusion
- DrugGemcitabine
IV Infusion
- DrugCarboplatin
IV Infusion
Outcome measures
Primary
Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)
PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. 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.
Time frame: Up to ~39 months
Overall Survival (OS) (sac-TMT versus TPC)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to ~61 months
Secondary
Overall Survival (OS) (sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus sac-TMT)
Time frame: Up to ~61 months
Progression-Free Survival (PFS) (sac-TMT plus pembrolizumab versus sac-TMT)
Time frame: Up to ~39 months
Objective Response Rate (ORR) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Time frame: Up to ~39 months
Duration of Response (DOR)
Time frame: Up to ~39 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) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Time frame: Baseline and up to ~61 months
Change from baseline in physical functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Time frame: Baseline and up to ~61 months
Change from baseline in emotional functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Time frame: Baseline and up to ~61 months
Change from baseline in fatigue score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Time frame: Baseline and up to ~61 months
Change from baseline in diarrhea score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Time frame: Baseline and up to ~61 months
Number of participants who experience one or more adverse events (AEs)
Time frame: Up to ~61 months
Number of participants who discontinue study treatment due to an AE
Time frame: Up to ~61 months
Eligibility criteria
Study locations (38)
USA Mitchell Cancer Institute ( Site 0090)
Mobile, Alabama, 36604
Ironwood Cancer & Research Centers ( Site 0036)
Chandler, Arizona, 85224
City of Hope ( Site 0097)
Duarte, California, 91010
City of Hope Lennar Foundation Cancer Center ( Site 0099)
Irvine, California, 92618
UCLA Department of Medicine - Hematology & Oncology ( Site 0047)
Los Angeles, California, 90095
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)
San Francisco, California, 94158
Yale New Haven Hospital ( Site 0001)
New Haven, Connecticut, 06520
Washington Hospital Center ( Site 0098)
Washington D.C., District of Columbia, 20010-2975
AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007)
Altamonte Springs, Florida, 32701
Orlando Health Cancer Institute ( Site 0012)
Orlando, Florida, 32806
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida, 33401
University Cancer & Blood Center, LLC ( Site 0023)
Athens, Georgia, 30607
St. Luke's Cancer Institute: Boise ( Site 0037)
Boise, Idaho, 83712
University of Illinois Cancer Center ( Site 0044)
Chicago, Illinois, 60612
MedStar Franklin Square Medical Center ( Site 0031)
Baltimore, Maryland, 21237
MedStar Good Samaritan Hospital ( Site 0079)
Baltimore, Maryland, 21239
MedStar Southern Maryland Hospital Center ( Site 0100)
Clinton, Maryland, 20735
MedStar Montgomery Medical Center ( Site 0078)
Olney, Maryland, 20832
Holy Cross Hospital ( Site 0091)
Silver Spring, Maryland, 20910
Cancer & Hematology Centers of Western Michigan ( Site 0026)
Grand Rapids, Michigan, 49503
Allina Health Cancer Institute ( Site 0069)
Minneapolis, Minnesota, 55407
Comprehensive Cancer Centers of Nevada ( Site 0015)
Las Vegas, Nevada, 89169
Renown Regional Medical Center ( Site 0005)
Reno, Nevada, 89502
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082)
Hackensack, New Jersey, 07601
New Mexico Oncology Hematology Consultants Ltd. ( Site 0019)
Albuquerque, New Mexico, 87109
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073)
Mineola, New York, 11501
Laura and Isaac Perlmutter Cancer Center ( Site 0003)
New York, New York, 10016
Rex Hematology Oncology Associates - Garner ( Site 0071)
Garner, North Carolina, 27529
SCRI Oncology Partners ( Site 7004)
Nashville, Tennessee, 37203
Tennessee Oncology ( Site 0018)
Nashville, Tennessee, 37203
Texas Oncology - DFW ( Site 8007)
Dallas, Texas, 75231
Texas Oncology - West Texas ( Site 8004)
El Paso, Texas, 79902
Kelsey-Seybold Clinic - North Houston Campus ( Site 0096)
Houston, Texas, 77014
Kelsey-Seybold Clinic ( Site 0040)
Houston, Texas, 77025
Texas Oncology - San Antonio ( Site 8001)
San Antonio, Texas, 78240
University of Utah, Huntsman Cancer Institute ( Site 0056)
Salt Lake City, Utah, 84112
Virginia Oncology Associates (VOA) ( Site 8002)
Norfolk, Virginia, 23502
Fred Hutchinson Cancer Center ( Site 0042)
Seattle, Washington, 98109