NCT01805076

MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer

Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Estrogen Receptor-negative Breast Cancer
• Progesterone Receptor-negative Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer
• Triple-negative Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Breast surgery
PROCEDURE	Magnetic resonance imaging
PROCEDURE	Mammography

Timeline

• Start date: 2014-05-21
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2013-03-06
• Last updated: 2025-09-05

Locations

179 sites across 1 country: United States