BO25430 - Trastuzumab Emtansine (T-DM1) Extension Study
Research type
Research Study
Full title
An open-label, multicentre extension study of Trastuzumab-MCC-DM1 (T-DM1) administered as a single agent or in combination with other anti-cancer therapies in patients previously treated with the equivalent T-DM1 regimen in a Genentech and/or F. Hoffmann-La Roche Ltd. sponsored T-DM1 study.
IRAS ID
77750
Contact name
Anne Armstrong
Sponsor organisation
Genentech Inc (Sponsor for the USA)
Eudract number
2010-021067-32
ISRCTN Number
n.a
Clinicaltrials.gov Identifier
n.a
Research summary
Breast cancer is the most common cancer in women. Metastatic breast cancer is incurable and so the primary goal of any treatment is to extend life and palliate symptoms while preserving quality of life. Overexpression of HER2 (the human epidermal growth factor receptor 2) is observed in about 20% of human breast cancers. Several lines of evidence support a direct role for HER2 overexpression in the aggressive growth and poor clinical outcomes associated with these tumours.Antibody-drug conjugates (monoclonal antibodies to which highly potent agents have been attached) represent a novel approach to delivering the highly potent cytotoxic agents directly to the cancer cells whilst limiting the effects of the agent elsewhere in the body. This allows a higher dose of the agent to be given. T-DM1 is a novel antibody-drug conjugate that is specifically designed for the treatment of HER2-positive cancers. This is an extension study to allow patients with HER2-positive metastatic breast cancer who have received T-DM1 in another Sponsor specified study to continue to receive T-DM1 treatment (if eligible) once the parent study has closed. Patients may continue to receive T-DM1 alone or in combination with paclitaxel or with pertuzumab (with or without paclitaxel).
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
11/EE/0483
Date of REC Opinion
10 Jan 2012
REC opinion
Further Information Favourable Opinion