Phase 3 Study of Sacituzumab Govitecan vs Physician's Choice in Subjects With Hormonal Receptor-Positive Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Who Have Failed at Least 2 Prior Chemotherapy Regimens
This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and safety of Sacituzumab Govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy regimens for metastatic disease.
Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle).
Recommended doses and schedules as per NCCN guidelines (with dose modifications if too toxic).
Eribulin; Capecitabine; Gemcitabine; Vinorelbine
18 Years and up
Accepting Healthy Volunteers?
- Female or male subjects aged ≥18 years at the time of signing the informed consent form
- Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) 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, 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 IULN, AST and 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]
- Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations
- History of significant cardiovascular disease or clinically significant ECG abnormality
- Patients with Gilbert's disease.
- Active infection requiring intravenous antibiotic use
- Patients 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 subjects who are candidates for curative intent therapy at the time of study enrollment