Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)
a study on Breast Cancer HER2
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at La Jolla, California and other locations
- Dates
- study startedestimated completion
Description
Summary
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.
Official Title
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
Details
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
Keywords
Metastatic Breast Cancer Sacituzumab Govitecan IMMU-132 TPC estrogen receptor progesterone receptor hormonal receptor Anti-TROP2 Unresectable or Metastatic Breast Cancer Human epidermal growth factor receptor 2 (HER2) Negative ADC Antibody Drug Conjugate Breast Neoplasms Gemcitabine Capecitabine Vinorelbine Eribulin
Eligibility
You can join if…
Open to people ages 18 years and up
- 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]
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 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
Locations
- University of California, San Diego Moores Cancer Center
accepting new patients
La Jolla California 92093 United States - Southern California Permanente Medical Group
accepting new patients
San Diego California 92120 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Immunomedics, Inc.
- ID
- NCT03901339
- Phase
- Phase 3
- Study Type
- Interventional
- Last Updated
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