Study of IMMU-132 in HR+ / HER2- MBC (TROPICS-02)
- 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
Approximately 400 eligible subjects will be randomized to one of the following 2 treatment arms: Investigational Arm: Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle). Control Arm: Recommended doses and schedules as per NCCN guidelines (with dose modifications if too toxic). Eribulin; Capecitabine; Gemcitabine; Vinorelbine
Trial Phase Phase III
Trial Type Treatment
- Primary ID IMMU-132-09
- Secondary IDs NCI-2019-03005
- Clinicaltrials.gov ID NCT03901339