MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
- Conditions
- Stage IA Breast CancerStage IB Breast CancerTriple-negative Breast CancerStage II Breast CancerEstrogen Receptor-negative Breast CancerProgesterone Receptor-negative Breast Cancer
- Interventions
- Procedure: Breast surgeryProcedure: Magnetic resonance imagingProcedure: Mammography
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 317
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 (control) Breast surgery Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery. Arm 2 (experimental) Magnetic resonance imaging Patients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy. Arm 2 (experimental) Mammography Patients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy. Arm 2 (experimental) Breast surgery Patients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy. Arm 1 (control) Mammography Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.
- Primary Outcome Measures
Name Time Method Local-regional recurrence (LRR) Up to 5 years
- Secondary Outcome Measures
Name Time Method Time to contralateral breast cancer Up to 5 years post-randomization 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 Re-operation rate Up to 5 years
Trial Locations
- Locations (179)
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
🇺🇸Jonesboro, Arkansas, United States
Kaiser Permanente-Deer Valley Medical Center
🇺🇸Antioch, California, United States
Smilow Cancer Hospital Care Center-Fairfield
🇺🇸Fairfield, Connecticut, United States
Dekalb Medical Center
🇺🇸Decatur, Georgia, United States
Bay Area Breast Surgeons Inc
🇺🇸Emeryville, California, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Kaiser Permanente Medical Center - Santa Clara
🇺🇸Santa Clara, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Helen F Graham Cancer Center
🇺🇸Newark, Delaware, United States
Kaiser Permanente-Oakland
🇺🇸Oakland, California, United States
Kaiser Permanente-Richmond
🇺🇸Richmond, California, United States
Kootenai Health - Coeur d'Alene
🇺🇸Coeur d'Alene, Idaho, United States
Northwest Community Hospital
🇺🇸Arlington Heights, Illinois, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Saint Alphonsus Cancer Care Center-Boise
🇺🇸Boise, Idaho, United States
Parkview Hospital Randallia
🇺🇸Fort Wayne, Indiana, United States
Kaiser Permanente-Stockton
🇺🇸Stockton, California, United States
IU Health West Hospital
🇺🇸Avon, Indiana, United States
McFarland Clinic PC - Ames
🇺🇸Ames, Iowa, United States
Saint Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Christiana Care Health System-Christiana Hospital
🇺🇸Newark, Delaware, United States
Memorial Hospital of Carbondale
🇺🇸Carbondale, Illinois, United States
Edward Hospital/Cancer Center
🇺🇸Naperville, Illinois, United States
Kootenai Clinic Cancer Services - Post Falls
🇺🇸Post Falls, Idaho, United States
NorthShore University HealthSystem-Glenbrook Hospital
🇺🇸Glenview, Illinois, United States
Elkhart Clinic
🇺🇸Elkhart, Indiana, United States
Physicians' Clinic of Iowa PC
🇺🇸Cedar Rapids, Iowa, United States
Sanford Broadway Medical Center
🇺🇸Fargo, North Dakota, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
NorthShore University HealthSystem-Highland Park Hospital
🇺🇸Highland Park, Illinois, United States
Michiana Hematology Oncology PC-Mishawaka
🇺🇸Mishawaka, Indiana, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
William Beaumont Hospital - Troy
🇺🇸Troy, Michigan, United States
Ascension Providence Hospitals - Novi
🇺🇸Novi, Michigan, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Capital Health Medical Center-Hopewell
🇺🇸Pennington, New Jersey, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Saint Luke's University Hospital-Bethlehem Campus
🇺🇸Bethlehem, Pennsylvania, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Southern Ohio Medical Center
🇺🇸Portsmouth, Ohio, United States
William Beaumont Hospital-Royal Oak
🇺🇸Royal Oak, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Cookeville Regional Medical Center
🇺🇸Cookeville, Tennessee, United States
Fox Valley Surgical Associates Limited
🇺🇸Appleton, Wisconsin, United States
ThedaCare Regional Cancer Center
🇺🇸Appleton, Wisconsin, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Prisma Health Cancer Institute - Butternut
🇺🇸Greenville, South Carolina, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
🇺🇸New York, New York, United States
Dickstein Cancer Treatment Center
🇺🇸White Plains, New York, United States
West Virginia University Healthcare
🇺🇸Morgantown, West Virginia, United States
University of Pennsylvania/Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Doctor's Hospital of Laredo
🇺🇸Laredo, Texas, United States
Sentara Leigh Hospital
🇺🇸Norfolk, Virginia, United States
ThedaCare Regional Medical Center - Appleton
🇺🇸Appleton, Wisconsin, United States
Holy Redeemer Hospital and Medical Center
🇺🇸Meadowbrook, Pennsylvania, United States
Prisma Health Cancer Institute - Eastside
🇺🇸Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
🇺🇸Greer, South Carolina, United States
Gibbs Cancer Center-Pelham
🇺🇸Greer, South Carolina, United States
Penn State Milton S Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Sanford Cancer Center Oncology Clinic
🇺🇸Sioux Falls, South Dakota, United States
Riddle Memorial Hospital
🇺🇸Media, Pennsylvania, United States
Prisma Health Cancer Institute - Faris
🇺🇸Greenville, South Carolina, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Aurora West Allis Medical Center
🇺🇸West Allis, Wisconsin, United States
Sanford USD Medical Center - Sioux Falls
🇺🇸Sioux Falls, South Dakota, United States
South Jordan Health Center
🇺🇸South Jordan, Utah, United States
Prisma Health Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States
Vince Lombardi Cancer Clinic-Two Rivers
🇺🇸Two Rivers, Wisconsin, United States
PeaceHealth Southwest Medical Center
🇺🇸Vancouver, Washington, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Aurora Medical Center in Summit
🇺🇸Summit, Wisconsin, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
🇺🇸Baltimore, Maryland, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Prisma Health Cancer Institute - Easley
🇺🇸Easley, South Carolina, United States
Advocate Illinois Masonic Medical Center
🇺🇸Chicago, Illinois, United States
Saint Agnes Hospital
🇺🇸Baltimore, Maryland, United States
Kaiser Permanente-Gaithersburg Medical Center
🇺🇸Gaithersburg, Maryland, United States
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Kaiser Permanente-Fresno
🇺🇸Fresno, California, United States
Enloe Medical Center
🇺🇸Chico, California, United States
USC / Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente-Fremont
🇺🇸Fremont, California, United States
Epic Care Partners in Cancer Care
🇺🇸Emeryville, California, United States
Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
Kaiser Permanente-Modesto
🇺🇸Modesto, California, United States
Saint Joseph Hospital - Orange
🇺🇸Orange, California, United States
Kaiser Permanente-Roseville
🇺🇸Roseville, California, United States
Kaiser Permanente-Santa Teresa-San Jose
🇺🇸San Jose, California, United States
Kaiser Permanente-San Rafael
🇺🇸San Rafael, California, United States
Kaiser Permanente-South San Francisco
🇺🇸South San Francisco, California, United States
Smilow Cancer Hospital Care Center-Trumbull
🇺🇸Trumbull, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
🇺🇸Hartford, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford
🇺🇸Waterford, Connecticut, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Edward Hospital/Cancer Center?Plainfield
🇺🇸Plainfield, Illinois, United States
Memorial Medical Center
🇺🇸Springfield, Illinois, United States
IU Health North Hospital
🇺🇸Carmel, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
🇺🇸Elkhart, Indiana, United States
Parkview Regional Medical Center
🇺🇸Fort Wayne, Indiana, United States
Oncology Associates at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
University of Kentucky/Markey Cancer Center
🇺🇸Lexington, Kentucky, United States
Spectrum Health at Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
🇺🇸Grand Rapids, Michigan, United States
Robert Wood Johnson University Hospital Somerset
🇺🇸Somerville, New Jersey, United States
Vassar Brothers Medical Center
🇺🇸Poughkeepsie, New York, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
🇺🇸Wilmington, North Carolina, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
WellSpan Health-York Hospital
🇺🇸York, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg
🇺🇸Boiling Springs, South Carolina, United States
Spartanburg Medical Center
🇺🇸Spartanburg, South Carolina, United States
Prisma Health Cancer Institute - Seneca
🇺🇸Seneca, South Carolina, United States
Sentara Cancer Institute at Sentara CarePlex Hospital
🇺🇸Hampton, Virginia, United States
Vince Lombardi Cancer Clinic - Oshkosh
🇺🇸Oshkosh, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
🇺🇸Sheboygan, Wisconsin, United States
Kaiser Permanente San Leandro
🇺🇸San Leandro, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Kaiser Permanente-San Francisco
🇺🇸San Francisco, California, United States
Huntsman Cancer Institute/University of Utah
🇺🇸Salt Lake City, Utah, United States
Wayne State University/Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Ascension Saint John Hospital
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Kaiser Permanente Northwest
🇺🇸Portland, Oregon, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
University of Rochester
🇺🇸Rochester, New York, United States
Kaiser Permanente-Redwood City
🇺🇸Redwood City, California, United States
Kaiser San Rafael-Gallinas
🇺🇸San Rafael, California, United States
Kaiser Permanente-Vallejo
🇺🇸Vallejo, California, United States
Kaiser Permanente-Santa Rosa
🇺🇸Santa Rosa, California, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Kaiser Permanente-Walnut Creek
🇺🇸Walnut Creek, California, United States
Smilow Cancer Hospital-Derby Care Center
🇺🇸Derby, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
🇺🇸North Haven, Connecticut, United States
The Community Hospital
🇺🇸Munster, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
University of Illinois
🇺🇸Chicago, Illinois, United States
Smilow Cancer Hospital Care Center - Guiford
🇺🇸Guilford, Connecticut, United States
University of Chicago Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
🇺🇸Evanston, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
🇺🇸Savannah, Georgia, United States
Saint Joseph's Regional Medical Center
🇺🇸Paterson, New Jersey, United States
University of Kansas Hospital-Westwood Cancer Center
🇺🇸Westwood, Kansas, United States
Michiana Hematology Oncology PC-Plymouth
🇺🇸Plymouth, Indiana, United States
Providence Saint Vincent Medical Center
🇺🇸Portland, Oregon, United States
Michiana Hematology Oncology PC-South Bend
🇺🇸South Bend, Indiana, United States
Owensboro Health Mitchell Memorial Cancer Center
🇺🇸Owensboro, Kentucky, United States
UMass Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Aurora Cancer Care-Grafton
🇺🇸Grafton, Wisconsin, United States
Kaiser Permanente-South Sacramento
🇺🇸Sacramento, California, United States
Kaiser Permanente - Sacramento
🇺🇸Sacramento, California, United States
The James Graham Brown Cancer Center at University of Louisville
🇺🇸Louisville, Kentucky, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Smilow Cancer Center/Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Montefiore Medical Center-Einstein Campus
🇺🇸Bronx, New York, United States
Montefiore Medical Center - Moses Campus
🇺🇸Bronx, New York, United States
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Kaiser Permanente Medical Center-Vacaville
🇺🇸Vacaville, California, United States
Surgical Associates of Neenah SC
🇺🇸Neenah, Wisconsin, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States