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MRI and Mammography before Surgery in Patients with Stage I-II Breast Cancer

Trial Status: Closed to Accrual

This randomized phase III trial studies how well magnetic resonance imaging (MRI) and mammography work compared to mammography alone in patients with stage I-II breast cancer. Diagnostic procedures, such as MRI and mammography, may help in planning cancer treatment.

Inclusion Criteria

  • Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0); diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded; for patients enrolled after receipt and completion of neoadjuvant chemotherapy, the clinical stage must be determined based on pre-chemotherapy assessment
  • 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 * HER2 status will be determined per the 2013 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines: ** HER2 is considered positive if a) there is IHC 3+ staining or b) positive using either single probe in situ hybridization (ISH) or dual probe ISH ** HER2 is considered negative if a) there is IHC 0 or 1+ staining or b) ISH negative using either single probe ISH or dual probe ISH * For patients enrolling after neoadjuvant therapy, the ER, PR, and HER2 markers are based on assessment prior to initiating neoadjuvant treatment
  • No patients with previous ipsilateral or contralateral 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 history of receiving endocrine therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures; these agents used previously as chemoprevention are allowed
  • Patients receiving neoadjuvant chemotherapy or recently completed neoadjuvant chemotherapy and will undergo surgery within 6 weeks are eligible
  • No patients scheduled to receive 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; for patients who have neoadjuvant therapy, eligibility for BCT is determined at completion of therapy; repeat mammogram +/- ultrasound (US) of the affected side only will be required at completion of neoadjuvant chemotherapy to determine eligibility for BCT
  • 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; for patients with multifocal or multicentric disease enrolled after completion of neoadjuvant chemotherapy, histologic confirmation of multifocality/multicentricity must have been completed before initiation of chemotherapy
  • 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 serum 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
  • Signed study-specific informed consent prior to registration

Arizona

Gilbert
Banner MD Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 602-747-9738

Arkansas

Jonesboro
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 870-936-7067

California

Antioch
Kaiser Permanente-Deer Valley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Chico
Enloe Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 530-332-3808
Emeryville
Bay Area Breast Surgeons Inc
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 510-835-9900
Epic Care Partners in Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 510-629-6682
Fremont
Kaiser Permanente-Fremont
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Fresno
Kaiser Permanente-Fresno
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Los Angeles
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451
Martinez
Contra Costa Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 925-957-5400
Modesto
Kaiser Permanente-Modesto
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Oakland
Bay Area Tumor Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 510-465-2242
Kaiser Permanente-Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
Saint Joseph Hospital - Orange
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 714-734-6220
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-827-8839
Redwood City
Kaiser Permanente-Redwood City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Richmond
Kaiser Permanente-Richmond
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Roseville
Kaiser Permanente-Roseville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
Kaiser Permanente - Sacramento
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente-South Sacramento
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Diego
Sharp Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 858-939-5062
San Francisco
Kaiser Permanente-San Francisco
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Jose
Kaiser Permanente-Santa Teresa-San Jose
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Leandro
Kaiser Permanente San Leandro
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Rafael
Kaiser Permanente-San Rafael
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser San Rafael-Gallinas
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Rosa
Kaiser Permanente-Santa Rosa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South San Francisco
Kaiser Permanente-South San Francisco
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Stockton
Kaiser Permanente-Stockton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vacaville
Kaiser Permanente Medical Center-Vacaville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vallejo
Kaiser Permanente-Vallejo
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Walnut Creek
Kaiser Permanente-Walnut Creek
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org

Connecticut

Derby
Smilow Cancer Hospital-Derby Care Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702
Fairfield
Smilow Cancer Hospital Care Center-Fairfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702
Guilford
Yale-New Haven Shoreline Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702
Hartford
Smilow Cancer Hospital Care Center at Saint Francis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702
New Haven
Smilow Cancer Center / Yale-New Haven Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702
Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702
North Haven
Yale-New Haven Hospital North Haven Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702
Waterford
Lawrence and Memorial Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-623-4450
Helen F Graham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-623-4450

Florida

Jacksonville
Baptist MD Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 904-202-7468

Georgia

Decatur
Dekalb Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 404-501-2738
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 912-819-5704

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Post Falls
Kootenai Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

Illinois

Arlington Heights
Northwest Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 847-618-4968
Carbondale
Memorial Hospital of Carbondale
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-457-5200
Chicago
Advocate Illinois Masonic Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-296-5360
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-8222
University of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-355-3046
Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 847-570-2109
Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 847-570-2109
Harvey
Ingalls Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 708-915-4673
Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 847-570-2109
Maywood
Loyola University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 708-226-4357
Naperville
Edward Hospital / Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-646-6075
Park Ridge
Advocate Lutheran General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 847-384-3621
Plainfield
Edward Hospital / Cancer Center?Plainfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-646-6075
Springfield
Memorial Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-788-3528
Urbana
Carle Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532

Indiana

Avon
IU Health West Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-278-5632
Carmel
IU Health North Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-278-5632
Elkhart
Elkhart Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-296-3903
Michiana Hematology Oncology PC-Elkhart
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-389-0414
Fort Wayne
Parkview Hospital Randallia
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 260-373-8888
Parkview Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-784-4673
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-278-5632
Mishawaka
Michiana Hematology Oncology PC-Mishawaka
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-237-1328
Munster
The Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 219-836-3349
Plymouth
Michiana Hematology Oncology PC-Plymouth
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-936-2585
South Bend
Memorial Hospital of South Bend
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-284-7370
Michiana Hematology Oncology PC-South Bend
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Robin T. Zon
Phone: 574-237-1328

Iowa

Ames
McFarland Clinic PC - Ames
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-239-4734
Cedar Rapids
Oncology Associates at Mercy Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 319-363-2690
Physicians' Clinic of Iowa PC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 319-297-2900

Kansas

Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-945-7552

Kentucky

Lexington
Baptist Health Lexington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-260-6425
University of Kentucky / Markey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 502-562-3429
Owensboro
Owensboro Health Mitchell Memorial Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 270-688-3691

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 410-955-8804
Saint Agnes Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 410-368-2910
Bethesda
Walter Reed National Military Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 301-319-2100
Gaithersburg
Kaiser Permanente-Gaithersburg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 301-816-7218

Massachusetts

Worcester
UMass Memorial Medical Center - University Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 508-856-3216

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Detroit
Ascension Saint John Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Henry Ford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-3721
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Flint
Genesys Hurley Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Grand Rapids
Mercy Health Saint Mary's
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Kalamazoo
West Michigan Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Novi
Ascension Providence Hospitals - Novi
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-849-5332
Pontiac
Saint Joseph Mercy Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Royal Oak
William Beaumont Hospital-Royal Oak
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695
Troy
William Beaumont Hospital - Troy
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695

Minnesota

Rochester
Mayo Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-776-0015

Missouri

Saint Louis
Missouri Baptist Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Springfield
Mercy Hospital Springfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520

Nebraska

Omaha
University of Nebraska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 402-559-6941

New Jersey

Paterson
Saint Joseph's Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 973-754-2207
Pennington
Capital Health Medical Center-Hopewell
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-255-3440
Somerville
Robert Wood Johnson University Hospital Somerset
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 908-685-2481
Toms River
Community Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 732-818-3882

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
Montefiore Medical Center-Einstein Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-767-9355
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-263-4434
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-639-7592
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-305-6361
Poughkeepsie
Vassar Brothers Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 845-483-6483
Rochester
University of Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 585-275-5830
White Plains
Dickstein Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 914-849-7582

North Carolina

Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-275-3853
Wilmington
New Hanover Regional Medical Center / Zimmer Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 910-342-3000
Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-323-5760

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-293-5066
Portsmouth
Southern Ohio Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Portland
Kaiser Permanente Northwest
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-335-2400
Providence Portland Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614

Pennsylvania

Bethlehem
Saint Luke's University Hospital-Bethlehem Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 484-503-4151
Bryn Mawr
Bryn Mawr Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 484-476-2649
Hershey
Penn State Milton S Hershey Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 717-531-3779
Meadowbrook
Holy Redeemer Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 215-938-3551
Media
Riddle Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 484-476-2649
Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 215-728-4790
University of Pennsylvania / Abramson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-474-9892
York
WellSpan Health-York Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-441-7957

Rhode Island

Providence
Rhode Island Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 401-444-1488

South Carolina

Easley
Prisma Health Cancer Institute - Easley
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Greenville
Prisma Health Cancer Institute - Butternut
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Eastside
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Greenville Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Greer
Gibbs Cancer Center-Pelham
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-560-6104
Prisma Health Cancer Institute - Greer
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Seneca
Prisma Health Cancer Institute - Seneca
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Spartanburg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-560-6104

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Cookeville
Cookeville Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 931-783-2714

Texas

Dallas
Baylor University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-422-9567
Fort Sam Houston
Brooke Army Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 210-916-4837
Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-632-6789
Laredo
Doctor's Hospital of Laredo
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 956-523-2650

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-424-2100
South Jordan
South Jordan Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-424-2100

Virginia

Hampton
Sentara Cancer Institute at Sentara CarePlex Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 757-388-2840
Norfolk
Sentara Leigh Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 757-388-5109
Sentara Norfolk General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 757-388-2406

Washington

Vancouver
PeaceHealth Southwest Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-514-3940

West Virginia

Morgantown
West Virginia University Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 304-293-7374

Wisconsin

Appleton
Fox Valley Surgical Associates Limited
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-574-3872
Radiology Associates of Appleton / ThedaCare Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-380-1500
ThedaCare Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-364-3605
Grafton
Aurora Cancer Care-Grafton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Green Bay
Aurora BayCare Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Madison
University of Wisconsin Hospital and Clinics
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-622-8922
Milwaukee
Aurora Saint Luke's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Sinai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Medical College of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-805-3666
Neenah
Surgical Associates of Neenah SC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-725-4527
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Summit
Aurora Medical Center in Summit
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
West Allis
Aurora West Allis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304

PRIMARY OBJECTIVE:

I. To compare the rates of local-regional recurrence (LRR) following attempted breast conserving therapy in a cohort of women with triple negative or human epidermal growth factor 2 (HER-2) amplified breast cancer randomized to preoperative staging with mammography (control arm) or mammography plus breast MRI (MRI arm).

SECONDARY OBJECTIVES:

I. 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.

II. To compare local recurrence rates between women who undergo breast-conserving therapy (BCT) on the control arm to women who undergo BCT on the MRI arm.

III. 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 radiation therapy [RT]) between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI.

IV. To compare the contralateral breast cancer rates in women randomized to preoperative breast MRI to those not receiving pre-operative breast MRI.

V. To compare the disease-free survival rates between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI.

VI. 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.

VII. To estimate the rate of MRI-guided localization assisted surgery.

VIII. To estimate the rate of multi-centric disease in the index breast for women in the MRI arm.

IX. To evaluate the accuracy of index lesion characteristics and other factors in predicting multi-centricity in the cohort randomized to breast MRI.

X. 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.

XI. To estimate the false positive rate for detection of multiple foci of breast cancer by MRI.

CORRELATIVE SCIENCE OBJECTIVES:

I. To compare patient reported quality of life (QOL) parameters between women randomized to the preoperative breast MRI arm and women randomized to the no pre-operative breast MRI arm.

II. To explore the impact that preoperative MRI has on patient QOL.

III. To compare the quality adjusted life years (QALY) in patients randomized to the preoperative breast MRI arm versus those randomized to the no preoperative breast MRI arm.

IV. To contribute to a bank of normative data of QOL outcomes in cancer patients.

V. To compare the estimated mean costs of breast cancer treatment between women randomized to the pre-operative breast MRI arm and women randomized to the no pre-operative breast MRI arm.

VI. To determine the incremental cost-effectiveness ratio of pre-operative breast MRI.

VII. To determine the impact of preoperative breast MRI using a net-benefit regression framework.

VIII. To determine molecular profile of chemonaive and chemoresistant breast cancer.

IX. To determine whether clinical-pathologic variables predict LRR.

X. To determine molecular characteristics that correlate with LRR and disease-free survival.

XI. To determine molecular alterations that develops between primary tumors and recurrent tumors.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo mammography and breast conserving surgery.

ARM B: Patients undergo mammography, MRI, and breast conserving surgery.

After completion of study, patients are followed up every 4 months for 2 years and then every 6 months for 3 years.

Trial Phase Phase III

Trial Type Diagnostic

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Isabelle Bedrosian

  • Primary ID A011104
  • Secondary IDs NCI-2012-02045, s14-01151, ACRIN 6694
  • Clinicaltrials.gov ID NCT01805076