Sacituzumab Govitecan (IMMU-132) in Relapsed/Refractory HR+/HER2- MBC
Research type
Research Study
Full title
Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimens
IRAS ID
260202
Contact name
Peter Schmid
Contact email
Sponsor organisation
Immunomedics, Inc.
Eudract number
2018-004201-33
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
122694, US IND:
Duration of Study in the UK
2 years, 10 months, 1 days
Research summary
Patients with metastatic breast cancer (MBC) who have disease progression after two or more treatments with chemotherapy are in great need of treatment options.
In this clinical study individuals who have failed at least two prior treatments, will test a new cancer treatment called Sacituzumab Govitecan (IMMU-132). Sacituzumab Govitecan will be compared with the Study Doctor’s choice of available approved cancer treatments. When entering the study, participants will be randomised (like the flip of a coin) to receive either the new study medication or one of the approved treatments in a 1:1 ratio.
Participants must have MBC of the type that is hormonal receptor positive (HR+) [meaning that hormones affect the cancer] and human epidermal growth factor receptor 2 (HER2) negative [the cancer cells have less of a protein called HER2 on the surface]. There are also other criteria that must be met to allow participation.
Sacituzumab Govitecan, is a combination of two parts of which one is an antibody (hRS) which will bind to an antigen (Trop-2) usually abundant on the cells of many types of cancer. The other part of Sacituzumab Govitecan is SN-38, an anticancer treatment used by itself to treat cancer for 20 years. The combination will target the tumour cells in the body and minimise the side effects from the cancer treatment.
Before entering the study, each person will be screened for eligibility. The screening period is maximum 28 days. Sacituzumab Govitecan will be received by infusion day 1 and 8 of 21-day cycles. Participation will continue as long as the treatment is safe and provides benefit to the participant.
Throughout the study, participants will be required to complete certain procedures, such as blood tests, questionnaires, CT and bone scans (and possibly MRI). Participants will be recruited at study sites in the UK and globally.
REC name
London - Fulham Research Ethics Committee
REC reference
19/LO/0981
Date of REC Opinion
16 Aug 2019
REC opinion
Further Information Favourable Opinion