The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery. Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient.
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). Secondary objectives are: * To compare the re-operation rates following attempted breast conserving therapy between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI * To compare local recurrence rates between women who undergo BCT on the control arm to women who undergo BCT on the MRI arm * To compare the conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis within the first 6 months of attempting BCT (prior to the administration of RT) between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI * To compare the contralateral breast cancer rates in women randomized to preoperative breast MRI to those not receiving pre-operative breast MRI * To compare the disease-free survival rates between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI * To compare breast cancer specific and overall survival outcomes of women assessed preoperatively with breast MRI to those assessed without the use of breast MRI * To estimate the rate of MRI-guided localization assisted surgery * To estimate the rate of multi-centric disease in the index breast for women in the MRI arm * To evaluate the accuracy of index lesion characteristics and other factors in predicting multi-centricity in the cohort randomized to breast MRI * To assess the positive predictive values (PPV) of MRI in detecting ipsilateral multi-centric disease and contralateral disease in women with breast cancer undergoing preoperative breast MRI * To estimate the false positive rate for detection of multiple foci of breast cancer by MRI All registered patients will be monitored for relapse and survival for 5 years from the date of surgery. Patients will be followed a minimum of every 4 months for the first 2 years from diagnosis and a minimum of every 6 months during years 3-5. Patients will be monitored for local, regional, distant relapse and vital status.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
319
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
Enloe Medical Center
Chico, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Local-regional Recurrence (LRR)
Time frame: Up to 5 years
Re-operation Rate
Time frame: Up to 5 years
Conversion Rate to Mastectomy Secondary to Persistent Positive Margins or Poor Cosmesis
Time frame: Within the first 6 months
Time to Contralateral Breast Cancer
Time frame: Up to 5 years post-randomization
Disease-free Survival (DFS)
Time frame: Up to 5 years post-randomization
Overall Survival
Time frame: Up to 5 years post-randomization
Breast Cancer Specific Survival Will be Measured
Time frame: Up to 5 years post-randomization
Rate of MRI-guided Localization Assisted Surgery (Arm B)
Time frame: Up to 5 years
False Positive Rate for MRI Detection of Multiple Disease Foci
Time frame: Up to 5 years
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Epic Care Partners in Cancer Care
Emeryville, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Kaiser Permanente-Fresno
Fresno, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
...and 169 more locations