LAST UPDATED
October 21, 2024
Clinicaltrials.gov ID
EudraCT ID
OVERVIEW
Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens (TROPiCS-02)
PROTOCOL SUMMARY
The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Metastatic Breast Cancer
Gender
N/A
Date
May 2019 - October 2023
Study Type
Interventional
Study Phase
Phase 3
Product
Sacituzumab Govitecan-hziy, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
Eligibility information
Inclusion criteria
- Documented evidence of hormone receptor-positive human epidermal growth factor receptor 2 negative (HER2-negative) (hormonal receptor-positive (HR+)/HER2-) metastatic breast cancer (MBC) confirmed.
- Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for metastatic disease:
- At least 1 taxane in any setting.
- At least 1 prior anticancer hormonal treatment in any setting.
- At least 1 cyclin-dependent kinase inhibitor 4/6 in any setting.
- Eligible for one of the chemotherapy options listed in the TPC arm.
- Documented disease progression after the most recent therapy.
- Adequate bone marrow function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500 per mm^3, platelets ≥ 100,000 per mm^3).
- Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to the Cockcroft and Gault formula .
- Adequate liver function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), or ≤ 3 IULN for individuals with documented Gilbert's syndrome, aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN (in the case of liver metastases ≤ 5.0 x IULN)).
- Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin (ß-hCG)).
Exclusion criteria
- Previous treatment with topoisomerase 1 Inhibitors as a free form or as other formulations.
- History of significant cardiovascular disease or clinically significant electrocardiogram (ECG) abnormality.
- Active serious infection requiring antibiotics.
- Any medical or other condition which, in the opinion of the Investigator, causes the individual to be medically unfit to receive sacituzumab govitecan or unsuitable for any reason.
- Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (113)
HonorHealth Research Institute
Avondale, Arizona, United States, 85392
Arizona Oncology Associates, PC
Tucson, Arizona, United States, 85704
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
University of California, San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States, 90017
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States, 90095
University of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Southern California Permanente Medical Group
San Diego, California, United States, 92120
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Yale University Cancer Center
New Haven, Connecticut, United States, 06520
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Mercy Medical Center, Medical Oncology & Hematology
Baltimore, Maryland, United States, 21202
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States, 20850
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63110
St. Vincent Frontier Cancer Center
Billings, Montana, United States, 59102
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
Laura and Isaac Perlmutter Cancer Center/NYU Langone Health
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
The West Clinic, PC dba West Cancer Center
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, United States, 75390
Houston Methodist Hospital/Houston Methodist Cancer Center
Houston, Texas, United States, 77030
Texas Oncology-Longview Cancer Center
Longview, Texas, United States, 75601
UT Health San Antonio - Mays Cancer Center
San Antonio, Texas, United States, 78229
Virginia Cancer Specialists
Arlington, Virginia, United States, 22205
Oncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care
Salem, Virginia, United States, 24153
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame
Montreal, Canada,
Centre Hospitalier Universitaire de Sherbrooke - Fleurimont
Sherbrooke, Canada,
Institut Régional du Cancer de Montpellier
Montpellier, France, 34298
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France, 42271
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt, Germany, 60389
DIAKOVERE Krankenhaus gGmbH Henriettenstift - Standort Kirchrode
Hanover, Germany,
Nationales Centrum für Tumorerkrankungen - Heidelberg
Heidelberg, Germany, 69120
Praxisklinik für Hämatologie und Onkologie Koblenz
Koblenz, Germany, 56068
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Piacenza, Italy, 29121
Hospital Quirónsalud Barcelona Instituto Oncologico Baselga
Barcelona, Spain, 08023
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Spain, 15706
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
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