Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: Sacituzumab Govitecan-hziy
    Administered intravenously
    Other names:
    • IMMU-132
    • GS-0132
Active Comparator
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
  • Drug: Eribulin
    Administered intravenously per NCCN guidelines
  • Drug: Capecitabine
    Administered orally per NCCN guidelines
  • Drug: Gemcitabine
    Administered intravenously per NCCN guidelines
  • Drug: Vinorelbine
    Administered intravenously per NCCN guidelines

More Details

Status
Completed
Sponsor
Gilead Sciences

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.