Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
NCT ID: NCT03901339
Last Updated: 2024-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
543 participants
INTERVENTIONAL
2019-05-08
2023-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sacituzumab Govitecan-hziy
Participants will receive sacituzumab govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 of a 21-day cycle.
Sacituzumab Govitecan-hziy
Administered intravenously
Treatment of Physician's Choice (TPC)
Participants will receive TPC determined prior to randomization from one of the following single-agent treatment:
Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic)
* Eribulin: 1.4 mg/m\^2 for North American sites, 1.23 mg/m\^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle
* Capecitabine: 1000-1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle
* Gemcitabine: 800-1200 mg/m\^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution
* Vinorelbine: 25 mg/m\^2 via IV on Day 1 weekly cycle per institution
Eribulin
Administered intravenously per NCCN guidelines
Capecitabine
Administered orally per NCCN guidelines
Gemcitabine
Administered intravenously per NCCN guidelines
Vinorelbine
Administered intravenously per NCCN guidelines
Interventions
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Sacituzumab Govitecan-hziy
Administered intravenously
Eribulin
Administered intravenously per NCCN guidelines
Capecitabine
Administered orally per NCCN guidelines
Gemcitabine
Administered intravenously per NCCN guidelines
Vinorelbine
Administered intravenously per NCCN guidelines
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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HonorHealth Research Institute
Avondale, Arizona, United States
Arizona Oncology Associates, PC
Tucson, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
University of California, San Diego Moores Cancer Center
La Jolla, California, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States
University of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center
Orange, California, United States
Southern California Permanente Medical Group
San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
University of Colorado
Aurora, Colorado, United States
Yale University Cancer Center
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Orlando Health, Inc.
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States
Northside Hospital, Inc.
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Mercy Medical Center, Medical Oncology & Hematology
Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Summit Medical Group
Florham Park, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Laura and Isaac Perlmutter Cancer Center/NYU Langone Health
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
The West Clinic, PC dba West Cancer Center
Germantown, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, United States
Texas Oncology-Denton South
Denton, Texas, United States
Houston Methodist Hospital/Houston Methodist Cancer Center
Houston, Texas, United States
Texas Oncology-Longview Cancer Center
Longview, Texas, United States
UT Health San Antonio - Mays Cancer Center
San Antonio, Texas, United States
Virginia Cancer Specialists
Arlington, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care
Salem, Virginia, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Chirec Cancer Institute
Brussels, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
CHU UCL Namur/Site Sainte Elisabeth
Namur, , Belgium
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame
Montreal, , Canada
Centre Hospitalier Universitaire de Sherbrooke - Fleurimont
Sherbrooke, , Canada
Hopital de Mercy
Ars-Laquenexy, , France
Institut Sainte Catherine
Avignon, , France
Hôpital Jean-Minjoz
Besançon, , France
Centre Georges-Francois Leclerc
Dijon, , France
Centre Leon Berard
Lyon, , France
Institut Régional du Cancer de Montpellier
Montpellier, , France
Institut Curie
Paris, , France
Hospices Civils de Lyon
Pierre-Bénite, , France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Institut Claudius Regaud
Toulouse, , France
HELIOS Klinikum Berlin-Buch
Berlin, , Germany
Gynakologisches Zentrum Bonn
Bonn, , Germany
Marienhospital Bottrop
Bottrop, , Germany
Städtisches Klinikum Dessau
Dessau, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Kliniken Essen-Mitte
Essen, , Germany
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt, , Germany
Onkologische Schwerpunktpraxis Eppendorf
Hamburg, , Germany
Gynakologisch-Onkologische Praxis Hannover
Hanover, , Germany
DIAKOVERE Krankenhaus gGmbH Henriettenstift - Standort Kirchrode
Hanover, , Germany
Nationales Centrum für Tumorerkrankungen - Heidelberg
Heidelberg, , Germany
Praxisklinik für Hämatologie und Onkologie Koblenz
Koblenz, , Germany
Universitätsmedizin Mannheim
Mannheim, , Germany
Klinikum Mutterhaus der Borromäerinnen
Trier, , Germany
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
Ospedale di Desio
Desio, , Italy
Ospedale Vito Fazzi di Lecce
Lecce, , Italy
Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliera San Gerardo di Monza
Monza, , Italy
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Piacenza, , Italy
IFO Istituto Nazionale dei Tumori Regina Elena
Rome, , Italy
Antoni van Leeuwenhoekziekenhuis
Amsterdam, , Netherlands
Medisch Centrum Haaglanden Antoniushove
Leidschendam, , Netherlands
Maastricht UMC+
Maastricht, , Netherlands
Complejo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital Quirónsalud Barcelona Instituto Oncologico Baselga
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Provincial de Castellón
Castillón, , Spain
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Instituto Oncologico Bureau (IOB)
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Royal Cornwall Hospital NHS Trust
Cornwell, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Gomez Pardo P, Jhaveri KL, Delaney R, Valdez T, Wang H, Motwani M, Yoon OK, Verret W, Tolaney SM. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1423-1433. doi: 10.1016/S0140-6736(23)01245-X. Epub 2023 Aug 23.
Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Pardo PG, Jhaveri KL, Delaney R, Fu O, Lin L, Verret W, Tolaney SM. Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol. 2022 Oct 10;40(29):3365-3376. doi: 10.1200/JCO.22.01002. Epub 2022 Aug 26.
Rugo HS, Bardia A, Tolaney SM, Arteaga C, Cortes J, Sohn J, Marme F, Hong Q, Delaney RJ, Hafeez A, Andre F, Schmid P. TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer. Future Oncol. 2020 Apr;16(12):705-715. doi: 10.2217/fon-2020-0163. Epub 2020 Mar 30.
Rugo HS, Schmid P, Tolaney SM, Dalenc F, Marme F, Shi L, Verret W, Shah A, Gharaibeh M, Bardia A, Cortes J. Health-related quality of life with sacituzumab govitecan in HR+/HER2- metastatic breast cancer in the phase III TROPiCS-02 trial. Oncologist. 2024 Sep 6;29(9):768-779. doi: 10.1093/oncolo/oyae088.
Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Spears PA, Tolaney SM. A plain language summary of the TROPiCS-02 study in patients with breast cancer (HR-positive/HER2-negative). Future Oncol. 2024 Apr;20(11):635-651. doi: 10.2217/fon-2023-0845. Epub 2024 Jan 25.
Rugo HS, Bardia A, Tolaney S. Sacituzumab govitecan for metastatic breast cancer: the TROPiCS-02 trial - Authors' reply. Lancet. 2024 Jul 27;404(10450):339-340. doi: 10.1016/S0140-6736(24)01049-3. No abstract available.
McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671.
Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O'Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020 Dec;31(12):1709-1718. doi: 10.1016/j.annonc.2020.09.004. Epub 2020 Sep 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2018-004201-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IMMU-132-09
Identifier Type: -
Identifier Source: org_study_id
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