MA.32
Research type
Research Study
Full title
A Phase III randomized trial of metformin versus placebo on recurrence and survival in early stage breast cancer.
IRAS ID
93026
Contact name
Dan Rea
Contact email
Sponsor organisation
NCIC Clinical Trials Group
Eudract number
2011-005230-18
Clinicaltrials.gov Identifier
Research summary
The MA.32 study will investigate whether a drug called metformin, commonly used in the treatment of diabetes, can reduce the risk of breast cancer returning. Metformin is widely used for the treatment of type II diabetes and appears to have potential in breast cancer patients.MA.32 is a multi-centre international phase III trial comparing metformin to a placebo treatment. All patients enrolled in the study will have had surgery and/or radiotherapy and/or chemotherapy for breast cancer in the last 12 months according to standard care. Following completion of standard treatment for breast cancer, patients will be allocated to one of two treatment groups at random: Group 1. Metformin tablets or Group 2. Placebo tablets. Patients will take their allocated tablets, once day for 4 weeks increasing to twice a day thereafter. Treatment will continue for 5 years unless the patient experiences unacceptable side effects or the subject's breast cancer returns. All patients will attend for study visits every 6 months in the first year, and annually thereafter. Patients will be asked to donate a tissue sample taken from their original breast cancer diagnosis/during surgery. Donation of tissue is optional but will be strongly encouraged. Patients will also provide mandatory blood samples at 3 timpoints (Baseline, 6 month visit and 5 year visit). These samples will be used to look for specific characteristics of the patients who respond to treatment (termed 'biomarkers'), to help plan the future use of this treatment and to learn more about breast cancer in general. The study is already open to recruitment in Canada and the USA. UK and Swiss participation is now proposed.
REC name
West of Scotland REC 1
REC reference
12/WS/0076
Date of REC Opinion
31 May 2012
REC opinion
Further Information Favourable Opinion