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).
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.
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There are 98 Locations for this study
Avondale Arizona, 85392, United States
Tucson Arizona, 85704, United States
Fayetteville Arkansas, 72703, United States
La Jolla California, 92093, United States
Los Angeles California, 90017, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
San Diego California, 92120, United States
San Francisco California, 94115, United States
Aurora Colorado, 80012, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06520, United States
Washington District of Columbia, 20007, United States
Miami Florida, 33136, United States
Miami Florida, 33176, United States
Orlando Florida, 32806, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60637, United States
Westwood Kansas, 66205, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21202, United States
Rockville Maryland, 20850, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55455, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63110, United States
Billings Montana, 59102, United States
Florham Park New Jersey, 07932, United States
New Brunswick New Jersey, 08903, United States
Albany New York, 12206, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10032, United States
New York New York, 10065, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15213, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
Dallas Texas, 75390, United States
Denton Texas, 76210, United States
Houston Texas, 77030, United States
Longview Texas, 75601, United States
San Antonio Texas, 78229, United States
Arlington Virginia, 22205, United States
Norfolk Virginia, 23502, United States
Salem Virginia, 24153, United States
Tacoma Washington, 98405, United States
Brussels , , Belgium
Brussels , , Belgium
Leuven , , Belgium
Namur , , Belgium
Halifax Nova Scotia, B3H 1, Canada
Montréal , , Canada
Sherbrooke , , Canada
Ars-Laquenexy , 57245, France
Avignon , 84918, France
Besançon , 25030, France
Dijon , 21000, France
Lyon , 69008, France
Montpellier , 34298, France
Paris , 75005, France
Pierre-Bénite , 69310, France
Saint-Priest-en-Jarez , 42271, France
Toulouse , 31300, France
Berlin , 13125, Germany
Bonn , 53111, Germany
Bottrop , 46236, Germany
Dessau , 06847, Germany
Erlangen , 91054, Germany
Essen , 45136, Germany
Frankfurt , 60389, Germany
Hamburg , 20249, Germany
Hannover , 30177, Germany
Hannover , , Germany
Heidelberg , 69120, Germany
Koblenz , 56068, Germany
Mannheim , 68167, Germany
Trier , , Germany
Brescia , , Italy
Desio , 20832, Italy
Lecce , , Italy
Milano , 20132, Italy
Monza , , Italy
Piacenza , 29121, Italy
Rome , 00144, Italy
Amsterdam , 1066, Netherlands
Leidschendam , , Netherlands
Maastricht , 6229, Netherlands
A Coruña , 15006, Spain
Barcelona , 08023, Spain
Barcelona , 08035, Spain
Barcelona , 08041, Spain
Castillón , 12002, Spain
Lleida , 25198, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Santiago De Compostela , 15706, Spain
Sevilla , 41013, Spain
Cornwell , , United Kingdom
Guildford , GU2 7, United Kingdom
Leicester , LE1 5, United Kingdom
London , EC1A , United Kingdom
London , SW3 6, United Kingdom
Manchester , , United Kingdom
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