Last updated on June 2020

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


Brief description of study

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.

Detailed Study 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

Clinical Study Identifier: NCT03901339

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Highlands Oncology Group

Fayetteville, AR United States
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Virginia Cancer Specialists

Arlington, VA United States
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Northside Hospital, Inc.

Atlanta, GA United States
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University of Colorado

Aurora, CO United States
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Orlando Health, Inc.

Orlando, FL United States
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Moffitt Cancer Center

Tampa, FL United States
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Magee-Womens Hospital of UPMC

Pittsburgh, PA United States
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Tennessee Oncology, PLLC

Nashville, TN United States
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Saint Luke's Cancer Institute

Kansas City, MO United States
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Yale University Cancer Center

New Haven, CT United States
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The Ohio State University

Columbus, OH United States
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Thomas Jefferson University

Philadelphia, PA United States
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Hopital de Mercy

Ars-Laquenexy, France
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Maastricht UMC+

Maastricht, Netherlands
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Miami Cancer Institute

Miami, FL United States
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Summit Medical Group

Florham Park, NJ United States
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Leicester Royal Infirmary

Leicester, United Kingdom
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Barts Health NHS Trust

London, United Kingdom
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Recruitment Status: Open


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