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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Study of IMMU-132 in HR+ / HER2- MBC (TROPICS-02)

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.
Breast
Phase III
Adults
Not Available
Not Available
Mayer, Ingrid
National
Vanderbilt University
12-26-2019
Treatment
VICCBRE1942
NCT03901339

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

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]



Exclusion Criteria:

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

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