MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
NCT ID: NCT01805076
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
317 participants
INTERVENTIONAL
2014-05-21
2025-05-27
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm 1 (control)
Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.
Breast surgery
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.
Breast surgery
Magnetic resonance imaging
Mammography
Interventions
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Breast surgery
Magnetic resonance imaging
Mammography
Eligibility Criteria
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Exclusion Criteria
* Patients must have either:
* Estrogen receptor (ER) negative/progesterone receptor (PR) negative (\< 10% by immunohistochemistry IHC staining) and HER-2 negative breast cancer OR
* ER negative/PR negative (\< 10% by IHC staining) and HER-2 positive tumors
* HER-2 status will be determined as per the 2013 ASCO CAP guidelines:
* HER-2 is considered positive if there is IHC 3+ staining or ISH positive using either single probe ISH or dual probe ISH
* HER-2 is considered negative if there is IHC 0 or 1+ staining or ISH negative using either single probe ISH or dual probe ISH
* No patients with previous ipsilateral invasive breast cancer or ductal carcinoma in situ (DCIS)
* No patients with bilateral breast cancer
* No patients with known deleterious mutations in breast cancer (BRCA) genes
* No current history of receiving hormonal therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures
* No history of chemotherapy for cancer within 6 months prior to registration
* No patients scheduled to receive neoadjuvant chemotherapy or partial breast irradiation following breast conserving surgery
* Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram. Women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial.
* No patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies. Multifocal disease that can be encompassed in a single operative bed can be enrolled.
* Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):
* No history of untreatable claustrophobia
* No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
* No history of sickle cell disease
* No contraindication to intravenous contrast administration
* No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance
* No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) \< 30 mL/min/1.73 m\^2 based on a creatinine level obtained within 28 days prior to registration
* Weight lower than that allowable by the MRI table
* No prior MRI of study breast within the 12 months prior to registration
* Non-pregnant and non-lactating. Patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration. Perimenopausal patients must be amenorrheic \> 12 months to be considered not of child-bearing potential
* ≥ 18 years of age
* Signed study-specific informed consent prior to registration
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
American College of Radiology Imaging Network
NETWORK
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Isabelle Bedrosian, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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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
Kaiser Permanente-Modesto
Modesto, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Saint Joseph Hospital - Orange
Orange, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Kaiser Permanente-Redwood City
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Kaiser Permanente - Sacramento
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser Permanente-San Rafael
San Rafael, California, United States
Kaiser San Rafael-Gallinas
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Kaiser Permanente-Stockton
Stockton, California, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States
Smilow Cancer Hospital Care Center - Guiford
Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Dekalb Medical Center
Decatur, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Edward Hospital/Cancer Center
Naperville, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
IU Health West Hospital
Avon, Indiana, United States
IU Health North Hospital
Carmel, Indiana, United States
Elkhart Clinic
Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, United States
Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
The Community Hospital
Munster, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
McFarland Clinic PC - Ames
Ames, Iowa, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, United States
Saint Agnes Hospital
Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Kaiser Permanente-Gaithersburg Medical Center
Gaithersburg, Maryland, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 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
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Ascension Providence Hospitals - Novi
Novi, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy
Troy, Michigan, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States
Capital Health Medical Center-Hopewell
Pennington, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, United States
University of Rochester
Rochester, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Dickstein Cancer Treatment Center
White Plains, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Holy Redeemer Hospital and Medical Center
Meadowbrook, Pennsylvania, United States
Riddle Memorial Hospital
Media, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
WellSpan Health-York Hospital
York, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 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
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Cookeville Regional Medical Center
Cookeville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Doctor's Hospital of Laredo
Laredo, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
South Jordan Health Center
South Jordan, Utah, United States
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton, Virginia, United States
Sentara Leigh Hospital
Norfolk, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Fox Valley Surgical Associates Limited
Appleton, Wisconsin, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
ThedaCare Regional Medical Center - Appleton
Appleton, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Surgical Associates of Neenah SC
Neenah, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Countries
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Other Identifiers
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ACRIN 6694
Identifier Type: -
Identifier Source: secondary_id
NCI-2012-02045
Identifier Type: REGISTRY
Identifier Source: secondary_id
A011104
Identifier Type: -
Identifier Source: org_study_id
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