for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion



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).

Official Title

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


Metastatic Breast Cancer, Breast Neoplasms, Gemcitabine, Capecitabine, Vinorelbine, Sacituzumab govitecan, Sacituzumab Govitecan-hziy, Eribulin


You can join if…

Open to people ages 18 years and up

  • 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 mm3, platelets ≥ 100,000 per mm3).
  • 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)).

You CAN'T join if...

  • 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.


  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco California 94115 United States
  • Los Angeles Hematology Oncology Medical Group
    Los Angeles California 90017 United States


in progress, not accepting new patients
Start Date
Completion Date
Gilead Sciences
Gilead Clinical Trials Website
Phase 3 research study
Study Type
About 543 people participating
Last Updated