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

  • STATUS
    Recruiting
  • End date
    May 26, 2023
  • participants needed
    400
  • sponsor
    Immunomedics, Inc.
Updated on 26 January 2021
kidney function tests
metastasis
capecitabine
HER2
cancer chemotherapy
vinorelbine
eribulin

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.

Description

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

Details
Condition Metastatic Breast Cancer, Stage IV Breast Cancer
Treatment Capecitabine, Gemcitabine, Eribulin, Vinorelbine, Sacituzumab govitecan
Clinical Study IdentifierNCT03901339
SponsorImmunomedics, Inc.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Metastatic Breast Cancer?
Do you have any of these conditions: Stage IV Breast Cancer or Metastatic Breast Cancer?
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 [-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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