Breast Cancer Clinical Trial

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician’s Choice in Participants With HR+/HER2- Metastatic Breast Cancer

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 Eligibility Criteria

Eligibility Criteria

Key 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 MBC including:

At least 1 prior anticancer hormonal treatment.
At least 1 cyclin-dependent kinase inhibitor 4/6 in the metastatic 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 hepatic function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN or 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))

Key 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
Individuals with Gilbert's disease.
Active serious infection requiring antibiotics
Individuals with a history of an anaphylactic reaction to irinotecan
Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
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.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

543

Study ID:

NCT03901339

Recruitment Status:

Active, not recruiting

Sponsor:

Gilead Sciences

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 98 Locations for this study

See Locations Near You

HonorHealth Research Institute
Avondale Arizona, 85392, United States
Arizona Oncology Associates, PC
Tucson Arizona, 85704, United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
University of California, San Diego Moores Cancer Center
La Jolla California, 92093, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles California, 90017, United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles California, 90095, United States
University of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
Southern California Permanente Medical Group
San Diego California, 92120, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Rocky Mountain Cancer Centers
Aurora Colorado, 80012, United States
University of Colorado
Aurora Colorado, 80045, United States
Yale University Cancer Center
New Haven Connecticut, 06520, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Miami Cancer Institute
Miami Florida, 33176, United States
Orlando Health, Inc.
Orlando Florida, 32806, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Emory University - Winship Cancer Institute
Atlanta Georgia, 30322, United States
Northside Hospital, Inc.
Atlanta Georgia, 30342, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
The University of Kansas Cancer Center
Westwood Kansas, 66205, United States
James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Mercy Medical Center, Medical Oncology & Hematology
Baltimore Maryland, 21202, United States
Maryland Oncology Hematology, P.A.
Rockville Maryland, 20850, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Allina Health, Virginia Piper Cancer Institute
Minneapolis Minnesota, 55407, United States
Masonic Cancer Center, University of Minnesota
Minneapolis Minnesota, 55455, United States
Saint Luke's Cancer Institute
Kansas City Missouri, 64111, United States
Washington University School of Medicine - Siteman Cancer Center
Saint Louis Missouri, 63110, United States
St. Vincent Frontier Cancer Center
Billings Montana, 59102, United States
Summit Medical Group
Florham Park New Jersey, 07932, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
New York Oncology Hematology, P.C.
Albany New York, 12206, United States
Laura and Isaac Perlmutter Cancer Center/NYU Langone Health
New York New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
The Ohio State University
Columbus Ohio, 43210, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Magee-Womens Hospital of UPMC
Pittsburgh Pennsylvania, 15213, United States
The West Clinic, PC dba West Cancer Center
Germantown Tennessee, 38138, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
Dallas Texas, 75390, United States
Texas Oncology-Denton South
Denton Texas, 76210, United States
Houston Methodist Hospital/Houston Methodist Cancer Center
Houston Texas, 77030, United States
Texas Oncology-Longview Cancer Center
Longview Texas, 75601, United States
UT Health San Antonio - Mays Cancer Center
San Antonio Texas, 78229, United States
Virginia Cancer Specialists
Arlington Virginia, 22205, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Oncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care
Salem Virginia, 24153, United States
Northwest Medical Specialties, PLLC
Tacoma Washington, 98405, 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, B3H 1, Canada
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 , 57245, France
Institut Sainte Catherine
Avignon , 84918, France
Hôpital Jean-Minjoz
Besançon , 25030, France
Centre Georges-Francois Leclerc
Dijon , 21000, France
Centre Leon Berard
Lyon , 69008, France
Institut Régional du Cancer de Montpellier
Montpellier , 34298, France
Institut Curie
Paris , 75005, France
Hospices Civils de Lyon
Pierre-Bénite , 69310, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez , 42271, France
Institut Claudius Regaud
Toulouse , 31300, France
HELIOS Klinikum Berlin-Buch
Berlin , 13125, Germany
Gynakologisches Zentrum Bonn
Bonn , 53111, Germany
Marienhospital Bottrop
Bottrop , 46236, Germany
Städtisches Klinikum Dessau
Dessau , 06847, Germany
Universitätsklinikum Erlangen
Erlangen , 91054, Germany
Kliniken Essen-Mitte
Essen , 45136, Germany
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt , 60389, Germany
Onkologische Schwerpunktpraxis Eppendorf
Hamburg , 20249, Germany
Gynakologisch-Onkologische Praxis Hannover
Hannover , 30177, Germany
DIAKOVERE Krankenhaus gGmbH Henriettenstift - Standort Kirchrode
Hannover , , Germany
Nationales Centrum für Tumorerkrankungen - Heidelberg
Heidelberg , 69120, Germany
Praxisklinik für Hämatologie und Onkologie Koblenz
Koblenz , 56068, Germany
Universitätsmedizin Mannheim
Mannheim , 68167, Germany
Klinikum Mutterhaus der Borromäerinnen
Trier , , Germany
Azienda Ospedaliera Spedali Civili di Brescia
Brescia , , Italy
Ospedale di Desio
Desio , 20832, Italy
Ospedale Vito Fazzi di Lecce
Lecce , , Italy
Ospedale San Raffaele
Milano , 20132, Italy
Azienda Ospedaliera San Gerardo di Monza
Monza , , Italy
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Piacenza , 29121, Italy
IFO Istituto Nazionale dei Tumori Regina Elena
Rome , 00144, Italy
Antoni van Leeuwenhoekziekenhuis
Amsterdam , 1066, Netherlands
Medisch Centrum Haaglanden Antoniushove
Leidschendam , , Netherlands
Maastricht UMC+
Maastricht , 6229, Netherlands
Complejo Hospitalario Universitario A Coruna
A Coruña , 15006, Spain
Hospital Quirónsalud Barcelona Instituto Oncologico Baselga
Barcelona , 08023, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona , 08041, Spain
Hospital Provincial de Castellón
Castillón , 12002, Spain
Hospital Universitari Arnau de Vilanova
Lleida , 25198, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28007, Spain
Instituto Oncologico Bureau (IOB)
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago De Compostela , 15706, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Royal Cornwall Hospital NHS Trust
Cornwell , , United Kingdom
Royal Surrey County Hospital
Guildford , GU2 7, United Kingdom
Leicester Royal Infirmary
Leicester , LE1 5, United Kingdom
Barts Health NHS Trust
London , EC1A , United Kingdom
The Royal Marsden NHS Foundation Trust
London , SW3 6, United Kingdom
The Christie NHS Foundation Trust
Manchester , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

543

Study ID:

NCT03901339

Recruitment Status:

Active, not recruiting

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider