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NCT01805076

PHASE3

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

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

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.

Official title: Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

319

Start Date

2014-05-21

Completion Date

2025-05-27

Last Updated

2026-06-26

Healthy Volunteers

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

Interventions

PROCEDURE

Breast surgery

PROCEDURE

Magnetic resonance imaging

PROCEDURE

Mammography

* 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

Locations (179)

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

And 79 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (179)