Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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).

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

Keywords

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

Eligibility

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 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 mm3, platelets ≥ 100,000 per mm3).

  • 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))

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
  • 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.

Locations

  • University of California, San Diego Moores Cancer Center
    La Jolla California 92093 United States
  • Southern California Permanente Medical Group
    San Diego California 92120 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT03901339
Phase
Phase 3
Study Type
Interventional
Last Updated