Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03901339|
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : September 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Sacituzumab Govitecan Drug: Eribulin Drug: Capecitabine Drug: Gemcitabine Drug: Vinorelbine||Phase 3|
Approximately 400 eligible subjects will be randomized to one of the following 2 treatment arms:
Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle).
Recommended doses and schedules as per NCCN guidelines (with dose modifications if too toxic).
Eribulin; Capecitabine; Gemcitabine; Vinorelbine
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 30, 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||May 2023|
Experimental: Sacituzumab Govitecan
Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle)
Drug: Sacituzumab Govitecan
Sacituzumab Govitecan (IMMU-132) is an antibody drug conjugate composed of the humanized monoclonal antibody, which binds to trophoblastic cell-surface antigen-2 (Trop-2); SN-38, a topoisomerase I inhibitor; and CL2A.
Other Name: IMMU-132
Active Comparator: TPC Comparator
TPC determined prior to randomization.
Per NCCN guidelines (with dose modifications for if toxic) Eribulin; Capecitabine; Gemcitabine; Vinorelbine
Eribulin (per NCCN guidelines)
Capecitabine (per NCCN guidelines)
Other Name: Xeloda
Gemcitabine (per NCCN guidelines)
Other Name: Gemzar
Vinorelbine (per NCCN guidelines)
Other Name: Navelbine
- Progression-free survival (PFS) [ Time Frame: within approximately 3 years ]PFS based on Investigator Assessment is defined as the time from randomization to the first clinical observation of disease progression or death.
- Objective (overall) response rate (ORR) [ Time Frame: within approximately 3 years ]ORR is defined as the percentage of participants who achieve objective CR or PR, confirmed by second assessment
- Overall Survival (OS) [ Time Frame: within approximately 4 years ]OS is defined as the time from randomization to death
- Duration of Response (DoR) [ Time Frame: within approximately 3 years ]DoR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901339
|Contact: Immunomedics Medical Informationfirstname.lastname@example.org|
|Study Director:||Immunomedics Medical Director||Immunomedics, Inc.|