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Spots Global Cancer Trial Database for MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Isabelle Bedrosian, MD

Affiliation: M.D. Anderson Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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