MRI Evaluation of the Contralateral Breast in Women With a Recent Diagnosis of Breast Cancer
Protocol-ACRIN 6667 Amendment 2, 10.9.03 [PDF]
SOC-ACRIN 6667 Amendment 2, 10.9.03 [PDF]
Principal Investigator: Constance Lehman, MD, PhD
Status: Primary-Aim Paper Published/Other Publications in Process
Main Objective: 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.
Participants: A total of 1,007 women with a recent history of breast cancer (negative or benign mammogram, and negative or benign clinical breast exam of the contralateral breast within 60 days prior to enrollment) will be enrolled into the trial at 22 centers in the US, Canada, and Germany.
Study Design Summary: 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.