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Can MRI and gene tests help avoid unnecessary mastectomies?

NCT ID NCT02352883

Knowledge-focused Sponsor: ECOG-ACRIN Cancer Research Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether combining MRI scans with genetic testing can help doctors choose the best treatment for people with ductal carcinoma in situ (DCIS), a very early form of breast cancer that hasn't spread. About 368 participants will have an MRI and a genetic test on their biopsy tissue. The goal is to see if these tools can predict who might need a mastectomy versus a less extensive surgery, and to better understand the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

368 people

The number who actually took part.

Started

Mar 2015

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

ductal breast carcinoma in situ

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ductal breast carcinoma in situ

Contacts and locations

Locations

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325, United States

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461, United States

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401, United States

  • Associates In Womens Health

    Wichita, Kansas, 67208, United States

  • Aultman Health Foundation

    Canton, Ohio, 44710, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010, United States

  • Cancer Care of Western North Carolina

    Asheville, North Carolina, 28801, United States

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801, United States

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042, United States

  • Cancer Center of Kansas - Main Office

    Wichita, Kansas, 67214, United States

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401, United States

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152, United States

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156, United States

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208, United States

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718, United States

  • Easton Hospital

    Easton, Pennsylvania, 18042, United States

  • Edward Hospital/Cancer Center

    Naperville, Illinois, 60540, United States

  • Edward Hospital/Cancer Center?Plainfield

    Plainfield, Illinois, 60585, United States

  • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

    Mount Holly, New Jersey, 08060, United States

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States

  • Greenwich Hospital

    Greenwich, Connecticut, 06830, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713, United States

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816, United States

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • IU Health West Hospital

    Avon, Indiana, 46123, United States

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426, United States

  • John Fitzgerald Kennedy Medical Center

    Atlantis, Florida, 33462, United States

  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120, United States

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92069, United States

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044, United States

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809, United States

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809, United States

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713, United States

  • Medical Oncology LLC

    Baton Rouge, Louisiana, 70809, United States

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601, United States

  • Memorial Medical Center

    Springfield, Illinois, 62781, United States

  • Memorial Regional Cancer Center Day Road

    Mishawaka, Indiana, 46544, United States

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141, United States

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804, United States

  • Midstate Medical Center

    Meriden, Connecticut, 06451, United States

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801, United States

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131, United States

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467-2490, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121, United States

  • Oconomowoc Memorial Hospital-ProHealth Care Inc

    Oconomowoc, Wisconsin, 53066, United States

  • Owensboro Health Mitchell Memorial Cancer Center

    Owensboro, Kentucky, 42303, United States

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301, United States

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801, United States

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850, United States

  • Phoenixville Hospital

    Phoenixville, Pennsylvania, 19460, United States

  • Pottstown Memorial Medical Center

    Pottstown, Pennsylvania, 19464, United States

  • Regional Hematology and Oncology PA

    Newark, Delaware, 19713, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063, United States

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876, United States

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908, United States

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303, United States

  • Springfield Clinic

    Springfield, Illinois, 62703, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050, United States

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214, United States

  • Virtua West Jersey Hospital Voorhees

    Voorhees Township, New Jersey, 08043, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188, United States

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17405, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.