MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer

NCT01805076 | Completed Phase 3

• 4 other identifiers: A011104ACRIN 6694U10CA037447NCI-2012-02045
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 179

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.

Conditions

Estrogen Receptor-negative Breast Cancer; Progesterone Receptor-negative Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Local-regional recurrence (LRR)

  Up to 5 years

Secondary Outcomes (8)

• Re-operation rate

  Up to 5 years

• Conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis

  Within the first 6 months

• Time to contralateral breast cancer

  Up to 5 years post-randomization

• Disease-free survival (DFS)

  Up to 5 years post-randomization

• Overall survival

  Up to 5 years post-randomization

Study Arms (2)

Arm 1 (control)

OTHER

Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.

Procedure: Breast surgery; Procedure: Mammography

Arm 2 (experimental)

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.

Procedure: Breast surgery; Procedure: Magnetic resonance imaging; Procedure: Mammography

Interventions

Breast surgery PROCEDURE

Arm 1 (control); Arm 2 (experimental)

Magnetic resonance imaging PROCEDURE

Arm 2 (experimental)

Mammography PROCEDURE

Arm 1 (control); Arm 2 (experimental)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Female. Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer. * 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. * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator
• American College of Radiology Imaging Network: collaborator

Study Sites (179)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401, United States

Location

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, 94531, United States

Location

Enloe Medical Center

Chico, California, 95926, United States

Location

Bay Area Breast Surgeons Inc

Emeryville, California, 94608, United States

Location

Epic Care Partners in Cancer Care

Emeryville, California, 94608, United States

Location

Kaiser Permanente-Fremont

Fremont, California, 94538, United States

Location

Kaiser Permanente-Fresno

Fresno, California, 93720, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Kaiser Permanente-Modesto

Modesto, California, 95356, United States

Location

Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Saint Joseph Hospital - Orange

Orange, California, 92868, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Kaiser Permanente-Redwood City

Redwood City, California, 94063, United States

Location

Kaiser Permanente-Richmond

Richmond, California, 94801, United States

Location

Kaiser Permanente-Roseville

Roseville, California, 95661, United States

Location

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

Location

Kaiser Permanente - Sacramento

Sacramento, California, 95825, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States

Location

Kaiser Permanente San Leandro

San Leandro, California, 94577, United States

Location

Kaiser Permanente-San Rafael

San Rafael, California, 94903, United States

Location

Kaiser San Rafael-Gallinas

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente-Stockton

Stockton, California, 95210, United States

Location

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, 95688, United States

Location

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

Location

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

Location

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418, United States

Location

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824, United States

Location

Smilow Cancer Hospital Care Center - Guiford

Guilford, Connecticut, 06437, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473, United States

Location

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

Location

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Dekalb Medical Center

Decatur, Georgia, 30033, United States

Location

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States

Location

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States

Location

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

Location

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Edward Hospital/Cancer Center

Naperville, Illinois, 60540, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Edward Hospital/Cancer Center?Plainfield

Plainfield, Illinois, 60585, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

IU Health West Hospital

Avon, Indiana, 46123, United States

Location

IU Health North Hospital

Carmel, Indiana, 46032, United States

Location

Elkhart Clinic

Elkhart, Indiana, 46514-2098, United States

Location

Michiana Hematology Oncology PC-Elkhart

Elkhart, Indiana, 46514, United States

Location

Parkview Hospital Randallia

Fort Wayne, Indiana, 46805, United States

Location

Parkview Regional Medical Center

Fort Wayne, Indiana, 46845, United States

Location

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Michiana Hematology Oncology PC-Mishawaka

Mishawaka, Indiana, 46545, United States

Location

The Community Hospital

Munster, Indiana, 46321, United States

Location

Michiana Hematology Oncology PC-Plymouth

Plymouth, Indiana, 46563, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Michiana Hematology Oncology PC-South Bend

South Bend, Indiana, 46601, United States

Location

McFarland Clinic PC - Ames

Ames, Iowa, 50010, United States

Location

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, 52402, United States

Location

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

Owensboro Health Mitchell Memorial Cancer Center

Owensboro, Kentucky, 42303, United States

Location

Saint Agnes Hospital

Baltimore, Maryland, 21229, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Kaiser Permanente-Gaithersburg Medical Center

Gaithersburg, Maryland, 20879, United States

Location

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ascension Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Mercy Health Saint Mary's

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Ascension Providence Hospitals - Novi

Novi, Michigan, 48374, United States

Location

Saint Joseph Mercy Oakland

Pontiac, Michigan, 48341, United States

Location

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital - Troy

Troy, Michigan, 48085, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States

Location

Capital Health Medical Center-Hopewell

Pennington, New Jersey, 08534, United States

Location

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, 08876, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

Dickstein Cancer Treatment Center

White Plains, New York, 10601, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

New Hanover Regional Medical Center/Zimmer Cancer Center

Wilmington, North Carolina, 28401, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Southern Ohio Medical Center

Portsmouth, Ohio, 45662, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, 18015, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Holy Redeemer Hospital and Medical Center

Meadowbrook, Pennsylvania, 19046, United States

Location

Riddle Memorial Hospital

Media, Pennsylvania, 19063, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

WellSpan Health-York Hospital

York, Pennsylvania, 17403, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

Location

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

Cookeville Regional Medical Center

Cookeville, Tennessee, 38501, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Doctor's Hospital of Laredo

Laredo, Texas, 78041, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

South Jordan Health Center

South Jordan, Utah, 84009, United States

Location

Sentara Cancer Institute at Sentara CarePlex Hospital

Hampton, Virginia, 23666, United States

Location

Sentara Leigh Hospital

Norfolk, Virginia, 23502, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

Location

Fox Valley Surgical Associates Limited

Appleton, Wisconsin, 54911, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

Location

ThedaCare Regional Medical Center - Appleton

Appleton, Wisconsin, 54911, United States

Location

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States

Location

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

Surgical Associates of Neenah SC

Neenah, Wisconsin, 54956, United States

Location

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States

Location

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081, United States

Location

Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States

Location

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241, United States

Location

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Mastectomy, Segmental; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Isabelle Bedrosian, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2013
• First Posted: March 6, 2013
• Study Start: May 21, 2014
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

US (179)