The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
Official Title: Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer
Study ID: NCT01805076
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Washington University School of Medicine, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, 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
Montefiore Medical Center-Einstein Campus, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, 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
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
Name: Isabelle Bedrosian, MD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR