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NCT02352883

MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ

Sponsor: ECOG-ACRIN Cancer Research Group

View on ClinicalTrials.gov

Summary

This clinical trial studies magnetic resonance imaging (MRI) and gene expression in diagnosing patients with abnormal cells in the breast duct that have not spread outside the duct. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. MRI may help find and diagnose patients with breast cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment. Genetic studies may help doctors predict the outcome of treatment and the risk for disease recurrence. Performing MRI with genetic studies may help determine the best treatment for patients with breast cancer in situ.

Official title: Prospective Study of Magnetic Resonance Imaging (MRI) and Multiparameter Gene Expression Assay in Ductal Carcinoma In Situ (DCIS)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

368

Start Date

2015-03-25

Completion Date

2027-11

Last Updated

2025-12-19

Healthy Volunteers

Conditions

Ductal Breast Carcinoma In Situ

Interventions

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Therapeutic Conventional Surgery

Undergo mastectomy

PROCEDURE

Therapeutic Surgical Procedure

Undergo wide local excision

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Endocrine Therapy

Undergo endocrine therapy

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Cytology Specimen Collection Procedure

Correlative studies

Inclusion Criteria: * Registration to Step 1: * Patients must have pathologically confirmed diagnosis of unilateral ductal carcinoma in situ with no evidence of microinvasive or invasive disease obtained by core needle biopsy within 4 months of registration; patients diagnosed by surgical excision are not eligible; patients with synchronous bilateral disease are not eligible; patients with synchronous bilateral disease (i.e., synchronous DCIS or invasive cancer) are not eligible * Patients will be staged prior to registration according to the clinical staging criteria adapted from the American Joint Committee on Cancer (AJCC) Cancer Staging Data Forms of the AJCC Cancer Staging Manual, 7th Edition, 2009; Note: For consistency purposes, AJCC 7th Edition will continue to be used throughout the entire study enrollment period * Required studies include a bilateral screening mammogram within 6 months and diagnostic mammogram of the affected breast within 3 months prior to registration * Patients must not have previous ipsilateral invasive breast cancer or DCIS * Patients must not have known deleterious mutations in breast cancer (BRCA) genes * Patients must not have received hormonal therapy (i.e., tamoxifen, raloxifene, and/or aromatase inhibitors) for prevention of breast cancer within 3 months of the biopsy documenting DCIS * Patients must not have history of chemotherapy for cancer within 6 months prior to registration * No prior history of breast radiotherapy that will prevent the use of radiotherapy for the present DCIS * Patients must be judged to be 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 the breasts within the 6 months prior to registration * Patients must be eligible for breast-conserving therapy (BCT) based on clinical examination and mammography; if ultrasound is performed, findings must also be consistent with eligibility for BCT * Patients must not have multicentric disease scheduled to undergo multiple lumpectomies; multifocal disease that can be encompassed in a single operative bed are eligible * Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 3 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study * Registration to Step 2: * MRI has been performed in Step 1, and additional imaging studies and biopsies performed if indicated * The clinician/patient has made the decision as to whether the patient will proceed to wide local excision or mastectomy * Registration to Step 3: * Patient's most recent surgery was wide local excision with or without re-excision and for which there was obtained clear (\>= 2 mm) margins at breast conserving surgery, and the pathology reveals pure DCIS; patients with invasive cancer or DCIS with microinvasion will not be registered on step 3, but will be followed for clinical outcomes * The OncotypeDX Patient Report of the DCIS Score from the OncotypeDX Breast Cancer Assay performed by Genomic Health on the excision tissue have been uploaded by the site into the Rave electronic case report forms (eCRF)

Locations (76)

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Kaiser Permanente-San Marcos

San Marcos, California, United States

Greenwich Hospital

Greenwich, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Midstate Medical Center

Meriden, Connecticut, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Regional Hematology and Oncology PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

John Fitzgerald Kennedy Medical Center

Atlantis, Florida, United States

Northwestern University

Chicago, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Edward Hospital/Cancer Center

Naperville, Illinois, United States

Edward Hospital/Cancer Center?Plainfield

Plainfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

IU Health West Hospital

Avon, Indiana, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Memorial Regional Cancer Center Day Road

Mishawaka, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Associates In Womens Health

Wichita, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Cancer Center of Kansas - Main Office

Wichita, Kansas, United States

Via Christi Regional Medical Center

Wichita, Kansas, United States

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Owensboro Health Mitchell Memorial Cancer Center

Owensboro, Kentucky, United States

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Medical Oncology LLC

Baton Rouge, Louisiana, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Hunterdon Medical Center

Flemington, New Jersey, United States

Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

Mount Holly, New Jersey, United States

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States

Virtua West Jersey Hospital Voorhees

Voorhees Township, New Jersey, United States

Albert Einstein College of Medicine

The Bronx, New York, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Cancer Care of Western North Carolina

Asheville, North Carolina, United States

Mission Hospital-Memorial Campus

Asheville, North Carolina, United States

Hope Women's Cancer Centers-Asheville

Asheville, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Aultman Health Foundation

Canton, Ohio, United States

The Christ Hospital

Cincinnati, Ohio, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Easton Hospital

Easton, Pennsylvania, United States

Adams Cancer Center

Gettysburg, Pennsylvania, United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Riddle Memorial Hospital

Media, Pennsylvania, United States

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Phoenixville Hospital

Phoenixville, Pennsylvania, United States

Pottstown Memorial Medical Center

Pottstown, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

WellSpan Health-York Hospital

York, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Roger Williams Medical Center

Providence, Rhode Island, United States

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Baylor University Medical Center

Dallas, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

Oconomowoc Memorial Hospital-ProHealth Care Inc

Oconomowoc, Wisconsin, United States

Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Clinical Research Directory

MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (76)