Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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).
Phase
Phase 3
Funding Agency/Sponsor
Industrial
Disease
Breast Cancer
Enrollment Eligibility
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.