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

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

Arizona

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

Arkansas

Jonesboro
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 870-936-7067
Email: Dawn.Smith@BMHCC.org

California

Antioch
Kaiser Permanente-Deer Valley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Emeryville
Bay Area Breast Surgeons Inc
Status: Active
Contact: Site Public Contact
Phone: 510-835-9900
Epic Care Partners in Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 510-629-6682
Fremont
Kaiser Permanente-Fremont
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Fresno
Kaiser Permanente-Fresno
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Los Angeles
USC / Norris Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 323-865-0451
Martinez
Contra Costa Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 925-957-5400
Modesto
Kaiser Permanente-Modesto
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Oakland
Bay Area Tumor Institute
Status: Active
Contact: Site Public Contact
Phone: 510-465-2242
Email: lradke@bati.org
Kaiser Permanente-Oakland
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-827-8839
Email: ucstudy@uci.edu
Redwood City
Kaiser Permanente-Redwood City
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Richmond
Kaiser Permanente-Richmond
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Roseville
Kaiser Permanente-Roseville
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
Kaiser Permanente - Sacramento
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente-South Sacramento
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Diego
Sharp Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 858-939-5062
Email: cathy.wood@sharp.com
San Francisco
Kaiser Permanente-San Francisco
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Jose
Kaiser Permanente-Santa Teresa-San Jose
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Leandro
Kaiser Permanente San Leandro
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Rafael
Kaiser Permanente-San Rafael
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser San Rafael-Gallinas
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Rosa
Kaiser Permanente-Santa Rosa
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South San Francisco
Kaiser Permanente-South San Francisco
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Stockton
Kaiser Permanente-Stockton
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vacaville
Kaiser Permanente Medical Center-Vacaville
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vallejo
Kaiser Permanente-Vallejo
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Walnut Creek
Kaiser Permanente-Walnut Creek
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org

Connecticut

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

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Helen F Graham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

Florida

Jacksonville
Baptist MD Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 904-202-7051

Georgia

Decatur
Dekalb Medical Center
Status: Active
Contact: Site Public Contact
Phone: 404-501-2738
Email: clinicaltrialsoncology@dekalbmedical.org
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Phone: 912-819-5704
Email: underberga@sjchs.org

Idaho

Coeur D'Alene
Kootenai Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Post Falls
Kootenai Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Illinois

Arlington Heights
Northwest Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 847-618-4968
Carbondale
Memorial Hospital of Carbondale
Status: Active
Contact: Site Public Contact
Phone: 618-457-5200
Email: clinical.research@sih.net
Chicago
University of Illinois
Status: Active
Contact: Site Public Contact
Phone: 312-355-3046
Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 847-570-2109
Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 847-570-2109
Harvey
Ingalls Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 708-915-4673
Email: clinicaltrials@ingalls.org
Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 847-570-2109
Naperville
Edward Hospital / Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 630-646-6075
Park Ridge
Advocate Lutheran General Hospital
Status: Active
Contact: Site Public Contact
Phone: 847-384-3621
Plainfield
Edward Hospital / Cancer Center?Plainfield
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 630-646-6075
Email: Cancerresearch@edward.org
Springfield
Memorial Medical Center
Status: Active
Contact: Site Public Contact
Phone: 217-788-3528
Urbana
Carle Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com

Indiana

Avon
IU Health West Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
Carmel
IU Health North Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
Fort Wayne
Parkview Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-784-4673
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
South Bend
Memorial Hospital of South Bend
Status: Active
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: Active
Contact: Site Public Contact
Phone: 515-956-4132
Cedar Rapids
Oncology Associates at Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 319-363-2690

Kansas

Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu

Kentucky

Lexington
Baptist Health Lexington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 859-260-6425
University of Kentucky / Markey Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 859-257-3379

Maryland

Baltimore
Saint Agnes Hospital
Status: Active
Contact: Site Public Contact
Phone: 410-368-2910
Bethesda
Walter Reed National Military Medical Center
Status: Active
Contact: Site Public Contact
Phone: 301-319-2100
Gaithersburg
Kaiser Permanente-Gaithersburg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 301-816-7218

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Detroit
Ascension Saint John Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Flint
Genesys Hurley Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Grand Rapids
Mercy Health Saint Mary's
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Novi
Ascension Providence Hospitals - Novi
Status: Active
Contact: Site Public Contact
Phone: 248-849-5332
Email: karen.fife@ascension.org
Pontiac
Saint Joseph Mercy Oakland
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Minnesota

Rochester
Mayo Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 855-776-0015

Missouri

Saint Louis
Missouri Baptist Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
Mercy Hospital Springfield
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 417-269-4520

New Jersey

Paterson
Saint Joseph's Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 973-754-2207
Email: HallL@sjhmc.org
Pennington
Capital Health Medical Center-Hopewell
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-255-3440
Somerville
Robert Wood Johnson University Hospital Somerset
Status: Active
Contact: Site Public Contact
Phone: 908-685-2481

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Einstein Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
New York
Memorial Sloan Kettering Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 212-639-7592
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-305-6361
Email: nr2616@cumc.columbia.edu
Poughkeepsie
Vassar Brothers Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 845-483-6483
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
White Plains
Dickstein Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 914-849-7582
Email: mcortese@wphospital.org

North Carolina

Wilmington
New Hanover Regional Medical Center / Zimmer Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 910-342-3000
Winston-Salem
Wake Forest University Health Sciences
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 336-713-6771

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Portsmouth
Southern Ohio Medical Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Portland
Kaiser Permanente Northwest
Status: Active
Contact: Site Public Contact
Phone: 503-335-2400
Email: information@kpchr.org

Pennsylvania

Hershey
Penn State Milton S Hershey Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 717-531-3779
Email: CTO@hmc.psu.edu
Meadowbrook
Holy Redeemer Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 215-938-3551
Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-474-9892

Rhode Island

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

South Carolina

Easley
Greenville Health System Cancer Institute-Easley
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville
Greenville Health System Cancer Institute-Butternut
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Faris
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greer
Gibbs Cancer Center-Pelham
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org
Greenville Health System Cancer Institute-Greer
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Seneca
Greenville Health System Cancer Institute-Seneca
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Spartanburg
Greenville Health System Cancer Institute-Spartanburg
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Spartanburg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org

Tennessee

Cookeville
Cookeville Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 931-783-2714

Texas

Fort Sam Houston
Brooke Army Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 210-916-4837
Houston
M D Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Email: askmdanderson@mdanderson.org
Laredo
Doctor's Hospital of Laredo
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 956-523-2650

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
South Jordan
South Jordan Health Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu

West Virginia

Morgantown
West Virginia University Healthcare
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Appleton
Fox Valley Surgical Associates Limited
Status: Active
Contact: Site Public Contact
Phone: 800-574-3872
Radiology Associates of Appleton / ThedaCare Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 920-380-1500
ThedaCare Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 920-364-3605
Email: Noreen.Wynn@thedacare.org
Grafton
Aurora Cancer Care-Grafton
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Milwaukee
Aurora Saint Luke's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Aurora Sinai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Froedtert and the Medical College of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-805-4380
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Summit
Aurora Medical Center in Summit
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
West Allis
Aurora West Allis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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 & Type

Trial Phase

Phase III

Trial Type

Diagnostic

Lead Organization

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Isabelle Bedrosian

Trial IDs

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