Study Details

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).

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

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

Rocky Mountain Cancer Centers

Aurora, Colorado, United States, 80012

University of Colorado

Aurora, Colorado, United States, 80045

Yale University Cancer Center

New Haven, Connecticut, United States, 06520

Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

Miami Cancer Institute

Miami, Florida, United States, 33176

Orlando Health, Inc.

Orlando, Florida, United States, 32806

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Northside Hospital, Inc.

Atlanta, Georgia, United States, 30342

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

Saint Louis, Missouri, United States, 63110

St. Vincent Frontier Cancer Center

Billings, Montana, United States, 59102

Summit Medical Group

Florham Park, New Jersey, United States, 07932

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

The Ohio State University

Columbus, Ohio, United States, 43210

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

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

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

Texas Oncology-Denton South

Denton, Texas, United States, 76210

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

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

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

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, B3H 1V7

Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame

Montréal, Canada

Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

Sherbrooke, Canada

Hopital de Mercy

Ars-Laquenexy, France, 57245

Institut Sainte Catherine

Avignon, France, 84918

Hôpital Jean-Minjoz

Besançon, France, 25030

Centre Georges-Francois Leclerc

Dijon, France, 21000

Centre Leon Berard

Lyon, France, 69008

Institut Régional du Cancer de Montpellier

Montpellier, France, 34298

Institut Curie

Paris, France, 75005

Hospices Civils de Lyon

Pierre-Bénite, France, 69310

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, France, 42271

Institut Claudius Regaud

Toulouse, France, 31300

HELIOS Klinikum Berlin-Buch

Berlin, Germany, 13125

Gynakologisches Zentrum Bonn

Bonn, Germany, 53111

Marienhospital Bottrop

Bottrop, Germany, 46236

Städtisches Klinikum Dessau

Dessau, Germany, 06847

Universitätsklinikum Erlangen

Erlangen, Germany, 91054

Kliniken Essen-Mitte

Essen, Germany, 45136

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt, Germany, 60389

Onkologische Schwerpunktpraxis Eppendorf

Hamburg, Germany, 20249

Gynakologisch-Onkologische Praxis Hannover

Hannover, Germany, 30177

DIAKOVERE Krankenhaus gGmbH Henriettenstift - Standort Kirchrode

Hannover, Germany

Nationales Centrum für Tumorerkrankungen - Heidelberg

Heidelberg, Germany, 69120

Praxisklinik für Hämatologie und Onkologie Koblenz

Koblenz, Germany, 56068

Universitätsmedizin Mannheim

Mannheim, Germany, 68167

Klinikum Mutterhaus der Borromäerinnen

Trier, Germany

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Ospedale di Desio

Desio, Italy, 20832

Ospedale Vito Fazzi di Lecce

Lecce, Italy

Ospedale San Raffaele

Milano, Italy, 20132

Azienda Ospedaliera San Gerardo di Monza

Monza, Italy

Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

Piacenza, Italy, 29121

IFO Istituto Nazionale dei Tumori Regina Elena

Rome, Italy, 00144

Antoni van Leeuwenhoekziekenhuis

Amsterdam, Netherlands, 1066

Medisch Centrum Haaglanden Antoniushove

Leidschendam, Netherlands

Maastricht UMC+

Maastricht, Netherlands, 6229

Complejo Hospitalario Universitario A Coruna

A Coruña, Spain, 15006

Hospital Quirónsalud Barcelona Instituto Oncologico Baselga

Barcelona, Spain, 08023

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Hospital de la Santa Creu I Sant Pau

Barcelona, Spain, 08041

Hospital Provincial de Castellón

Castillón, Spain, 12002

Hospital Universitari Arnau de Vilanova

Lleida, Spain, 25198

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28007

Instituto Oncologico Bureau (IOB)

Madrid, Spain, 28034

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Hospital Clinico Universitario de Santiago de Compostela

Santiago De Compostela, Spain, 15706

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Royal Cornwall Hospital NHS Trust

Cornwell, United Kingdom

Royal Surrey County Hospital

Guildford, United Kingdom, GU2 7XX

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Barts Health NHS Trust

London, United Kingdom, EC1A 7BE

The Royal Marsden NHS Foundation Trust

London, United Kingdom, SW3 6JJ

The Christie NHS Foundation Trust

Manchester, United Kingdom

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer (TROPiCS-02)