IMMU-132 in Breast Cancer
Research type
Research Study
Full title
An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan versus Treatment of Physician Choice in Patients with Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments
IRAS ID
233163
Contact name
Anne Armstrong
Contact email
Sponsor organisation
Immunomedics, Inc.
Eudract number
2017-003019-21
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
The purpose of the study is to test if the study drug is safe and effective at treating patients with metastatic triple-negative breast cancer.
About 328 people will participate in the study. Eligible patients will be randomly assigned to receive treatment with either the study drug (arm A) or the treatment of physician’s choice (arm B). For the treatment of physician’s choice (TPC), the patient will be offered one drug from a list of standard of care drugs available. This will be an approved and marketed drug that the physician would prescribe for the patient if they were not participating in the study.
Patients in arm A will receive the study drug, via intravenous infusion, on days 1 and 8 of each cycle. Each cycle for arm A patients is 3 weeks (21 days) long. Patients in arm B will be given their TPC according to the prescribing guidelines at the hospital. Depending on which drug is chosen, one cycle in arm B will be either 3 weeks (21 days) or 4 weeks (28 days) long.
A number of assessments and procedures will be performed during the study, including physical examinations, quality of life questionnaires, blood and urine sample assessments, 12-lead ECGs (electrocardiograms) and CT/MRI scans to determine disease status. These assessments are performed as part of the evaluation to determine if the study drug is safe and effective.
REC name
North West - Haydock Research Ethics Committee
REC reference
17/NW/0698
Date of REC Opinion
21 Dec 2017
REC opinion
Favourable Opinion