Lois Shepherd, MDCM, FRCPC
Professor, Department of Pathology and Molecular Medicine, Queen's University, Kingston, Ontario
NCIC Clinical Trials Group
2009-2010 BCRF Project
Co-investigator: Pamela J. Goodwin, MD, MSc., FRCP(C), Mount Sinai Hospital, University of Toronto
On behalf of the NCIC Clinical Trials Group
MA.32 is a multicenter intergroup Phase 3 randomized clinical trial that will evaluate the impact of metformin (a commonly used anti-diabetes drug) versus placebo on invasive disease-free survival in 3582 women with high risk, early stage breast cancer. Major North American co-operative clinical trials groups will participate in this study, with initiation of enrollment anticipated in early 2010. It is estimated study subjects will be enrolled over 3 years and that the primary statistical analysis will take place 3 years later. BCRF is supporting distribution of the study drug (metformin or placebo) to participating centers.
Mid-Year Progress Report:
The researchers are finalizing protocol development for a metformin intervention study in locally advanced and metastatic breast cancer. After study over the past few months, they decided to extend the study population to include not only subjects with locally advanced breast cancer but also those with metastatic breast cancer, and they now will also evaluate the effect of metformin association with chemotherapy, and enhance their planned focus on gene expression. As a result of the change in study design, the protocol that was developed for this study is under revision and the initiation of this study is delayed. The researchers now forecast that the study will activate in June or July.
Bio:
Dr. Shepherd is a Hematopathologist and Professor in the Department of Pathology and Molecular Medicine at Queen’s University in Kingston, Ontario and has worked as a Physician Coordinator and Senior Investigator at the NCIC Clinical Trial Group since 1988. Dr. Shepherd has been responsible for oversight of the Breast and Hematology trial activity within the group for the last 20 years. As well, she is the Operational Director of the Tumour, Tissue and Data Repository established in 1997 which is the biorepository for tissue collected in association with the Group’s clinical trials. Dr. Shepherd’s interests are in hematologic malignancies, transfusion medicine, breast cancer, translational research and biobanking. She has more than 70 peer-reviewed publications.
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