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This is a randomized trial of preoperative breast MRI in patients deemed eligible for breast-conserving surgery by conventional clinical criteria will provide important information about the clinical and biologic relevance of occult disease identified by MRI alone. Patients will be assigned to standard pre-operative breast cancer disease assessment without the addition of MRI prior to breast-conserving surgery or standard pre-operative breast cancer disease assessment with the use of MRI prior to breast-conserving surgery. The primary objective is to compare the rates of local-regional recurrence (LRR) following attempted breast-conserving therapy in a cohort of women with triple-negative or HER-2 amplified breast cancer randomized to preoperative staging with mammography (control arm) or mammography plus breast MRI (MRI arm). Arm 1 (control) Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast-conserving surgery. Interventions: Procedure: Breast surgery Procedure: Mammography Arm 2 (experimental) Patients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast-conserving surgery or mastectomy. Interventions: Procedure: Breast surgery Procedure: Magnetic resonance imaging Procedure: Mammography
Patients must have either:
HER-2 status will be determined as per the 2013 ASCO CAP guidelines:
Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):
Kathy Queen, RN864-560-1044 or firstname.lastname@example.org
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