Principal Investigator: Constance Lehman, M.D., Ph.D.
Protocol Statistician: Constantine Gatsonis, Ph.D.
Lead Biostatistician: Lucy Hanna, MS, MAT
Lead Data Manager: Glenna Gabrielli, B.S., MT
Project Manager: Ashley Fails, BA
The primary aim of this study is to determine the cancer yield of MRI in the contralateral breast of women with a recent breast cancer diagnosis and no known disease by mammography or clinical breast exam in the contralateral breast. A total of 1,000 women with a recent breast cancer diagnosis will be enrolled into the trial at 21 centers in the US, Canada and Germany. Women with a history of breast cancer, negative or benign mammogram, and negative or benign clinical breast exam of the contralateral breast within 90 days prior to the MRI will be invited to participate. All women will undergo MR evaluation of the contralateral breast. Truth regarding breast cancer status will be determined through the results of a breast biopsy, if that occurs, or as a result of a 24-month follow-up without clinical evidence of disease.
Secondary aims include assessing sensitivity, specificity and positive predictive values (PPV forcall back/additional imaging and PPV for biopsy recommendation) and ROC curves of MRI in evaluating the contralateral breast of women with recent diagnosis of breast cancer. In addition, preliminary evaluation of the influence of breast density, age, and tumor histology on the yield of MRI will be performed.
For full protocol text and data forms, click here