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

Phase 3

Completed

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

• Registration Number: NCT01805076
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Study Timeline

• Study First Submitted: 2013-02-24
• Study First Submitted QC: 2013-03-04
• Study First Posted: 2013-03-06
• Study Start: 2014-05-21
• Primary Completion: 2025-05-27
• Study Completion: 2025-05-27
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-03
• Last Update Posted: 2025-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 317

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Local-regional recurrence (LRR)	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis	Within the first 6 months
Disease-free survival (DFS)	Up to 5 years post-randomization
Breast cancer specific survival will be measured	Up to 5 years post-randomization
Rate of MRI-guided localization assisted surgery (Arm B)	Up to 5 years
Overall survival	Up to 5 years post-randomization
False positive rate for MRI detection of multiple disease foci	Up to 5 years
Time to contralateral breast cancer	Up to 5 years post-randomization
Re-operation rate	Up to 5 years

Trial Locations

Locations (179)

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

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

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