BO25734/TDM4997g:T-DM1 vs Treatment of Physician's choice in HER2+ MBC
Research type
Research Study
Full title
A phase III randomised, multi-centre, two-arm, open-label trial to evaluate the efficacy of T-DM1 compared with treatment of physician's choice in patients with HER2-positive metastatic breast cancer who have received at least two prior regimens of HER2-directed therapy.
IRAS ID
86989
Contact name
Stephen Chan
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2011-000509-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 3 months, 30 days
Research summary
Breast cancer is the most common cancer in women and the second most common cause of cancer related death in women worldwide. Metastatic Breast Cancer (MBC) is incurable, with the primary goal of treatment being to extend life and relieve symptoms while preserving quality of life.
In about 20% of breast cancers, the cancer cells express unusually high levels of a receptor called the HER2 receptor and these cancers (known as “HER2 positive breast cancer”) have a poor prognosis when treated with standard chemotherapy treatments. The development in the 1990s of a drug called “trastuzumab” provided patients who had HER2 positive breast cancer with a better outcome than chemotherapy alone. However, despite the improvements in survival that have been demonstrated following treatment with trastuzumab, virtually all patients with HER2 positive MBC develop progressive disease.
This clinical trial is looking to see how effective a new drug “trastuzumab emtansine” is, compared with standard treatment for HER2 positive MBC in patients who’s disease has become worse, despite receiving previous treatment with 2 recognised HER2-targetted therapies. Trastuzumab emtansine contains a monoclonal antibody (trastuzumab) that delivers a linked chemotherapy agent (DM1) to the HER2 positive cancer cells. Eligible patients will be assigned randomly to be treated with trastuzumab emtansine or to receive a standard 'Treatment of their Physician’s Choice' (TPC).
Participants assigned to the trastuzumab emtansine treatment arm will receive treatment every 3 weeks. For participants assigned to the TPC arm the therapy may be a single drug or a drug combination and may consist of an infusion and/or an oral medication. Participants will remain on the treatment assigned until their disease gets worse or they are withdrawn for another reason. Once participants are withdrawn from the study they will continue to be followed to check on their health status until the study ends.
REC name
London - Harrow Research Ethics Committee
REC reference
11/LO/1750
Date of REC Opinion
2 Dec 2011
REC opinion
Further Information Favourable Opinion