MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ
NCT ID: NCT02352883
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
368 participants
INTERVENTIONAL
2015-03-25
2027-11-30
Brief Summary
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Detailed Description
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I. To estimate the proportion of patients with ductal carcinoma in situ (DCIS) diagnosed on core needle biopsy judged to be breast conservation candidates based upon standard imaging (mammography +/- sonography) and physical examination (a) who convert to mastectomy in step 1 based on MRI findings, and (b) who have a mastectomy as the final surgical procedure in step 2.
SECONDARY OBJECTIVES:
I. To assess the relation between baseline clinical covariates (e.g., tumor grade, necrosis, histologic type, mammographic lesion size), MRI morphologic and kinetic features, and the DCIS score.
II. To assess the diagnostic accuracy of MRI in extent of disease evaluation in patients with DCIS.
III. To estimate the proportion of patients who require re-operation because of inadequate excision after MRI.
IV. To estimate the proportion of patients who proceed to mastectomy after an initial attempt at wide local excision because of either inadequate tumor-free margins (\< 2 mm), or other reasons.
V. To estimate the 5-year and 10-year ipsilateral breast event (in situ and invasive) rate (IBE) among women with DCIS assessed with MRI preoperatively and treated with wide local excision without radiation therapy (if there is a low DCIS score) or with radiation therapy (if there is an intermediate-high DCIS score).
VI. To estimate the proportion of women with DCIS who receive treatment that is concordant with their treatment goals and concerns.
VII. To estimate the proportion of women with DCIS whose decision autonomy preference was concordant with perceived level of decision involvement.
VIII. To assess decision quality using knowledge score and decision process. IX. To assess concordance between decision autonomy preference and perceived level of decision involvement, knowledge and decision process scores as independent predictors of decision satisfaction at the first post-operative visit.
X. To assess the relationship of patient-reported outcomes and disease-specific covariates, and quality of life after treatment.
XI. To assess the role of disease status, diagnostic test results and surgeon recommendation as predictors of treatment received.
XII. To compare the patient-reported diagnostic testing burden of bilateral mammography and MRI as measured by Testing Morbidities Index (TMI).
OUTLINE:
STEP 1:
ARM A: Patients undergo MRI prior to surgery. Patients undergo additional imaging and/or biopsies if indicated based on MRI.
STEP 2: Patients are assigned to 1 of 2 treatment arms based on the results of the MRI.
ARM B: Patients undergo a mastectomy. Patients do not register for Step 3.
ARM C: Patients undergo wide local excision +/- re-excision. Patients may cross-over to Arm B if mastectomy is indicated. Tissue samples collected during surgery are used to calculate the DCIS score using genetic analysis testing. Patients may then proceed to Step 3.
STEP 3: Patients are assigned to 1 of 2 treatment arms based on the results of the DCIS score test.
ARM D (DCIS score \< 39): Patients undergo endocrine therapy as directed.
ARM E (DCIS score \>= 39): Patients undergo radiation therapy and endocrine therapy as directed.
After completion of study treatment, patients are followed up every 6 months for 5 years and then every 12 months for 5 years.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Arm D (endocrine therapy)
Patients undergo endocrine therapy as directed.
Endocrine Therapy
Undergo endocrine therapy
Quality-of-Life Assessment
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Cytology Specimen Collection Procedure
Correlative studies
Arm E (radiation therapy, endocrine therapy)
Patients undergo radiation therapy and endocrine therapy as directed.
Radiation Therapy
Undergo radiation therapy
Endocrine Therapy
Undergo endocrine therapy
Quality-of-Life Assessment
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Arm A (MRI)
Patients undergo MRI prior to surgery. Patients undergo additional imaging and/or biopsies if indicated based on MRI.
Magnetic Resonance Imaging
Undergo MRI
Quality-of-Life Assessment
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Cytology Specimen Collection Procedure
Correlative studies
Arm B (mastectomy)
Patients undergo a mastectomy. Patients do not register for Step 3.
Therapeutic Conventional Surgery
Undergo mastectomy
Quality-of-Life Assessment
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Cytology Specimen Collection Procedure
Correlative studies
Arm C (wide local excision)
Patients undergo wide local excision +/- re-excision. Patients may cross-over to Arm B if mastectomy is indicated. Tissue samples collected during surgery are used to calculate the DCIS score using genetic analysis testing. Patients may then proceed to Step 3.
Therapeutic Surgical Procedure
Undergo wide local excision
Quality-of-Life Assessment
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Cytology Specimen Collection Procedure
Correlative studies
Interventions
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Magnetic Resonance Imaging
Undergo MRI
Therapeutic Conventional Surgery
Undergo mastectomy
Therapeutic Surgical Procedure
Undergo wide local excision
Radiation Therapy
Undergo radiation therapy
Endocrine Therapy
Undergo endocrine therapy
Quality-of-Life Assessment
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Cytology Specimen Collection Procedure
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
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Principal Investigators
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Constance Lehman
Role: PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Locations
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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
Countries
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References
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Khan SA, Romanoff J, Gatsonis C, Rahbar H, Carlos R, Badve S, Wright J, Corsetti RL, Lehman CD, Spell DW, Han LK, Bumberry JR, Gareen I, Snyder BS, Wagner LI, Miller KD, Comstock C, Sparano JA. Radiotherapy With a 12-Gene Expression Assay for Ductal Carcinoma In Situ: A Randomized Clinical Trial. JAMA Oncol. 2025 Oct 16:e254079. doi: 10.1001/jamaoncol.2025.4079. Online ahead of print.
Dunsmore VJ, Snyder BS, Gareen IF, Lehman CD, Khan SA, Romanoff J, Gatsonis C, Corsetti RL, Rahbar H, Spell DW, Han LK, Bumberry JR, Miller KD, Sparano JA, Comstock C, Park E, Wagner LI, Carlos RC. Quality of Life Among Patients With Ductal Carcinoma In Situ. JAMA Netw Open. 2025 Jul 1;8(7):e2518887. doi: 10.1001/jamanetworkopen.2025.18887.
Slavkova KP, Kang R, Kazerouni AS, Biswas D, Belenky V, Chitalia R, Horng H, Hirano M, Xiao J, Corsetti RL, Javid SH, Spell DW, Wolff AC, Sparano JA, Khan SA, Comstock CE, Romanoff J, Gatsonis C, Lehman CD, Partridge SC, Steingrimsson J, Kontos D, Rahbar H. MRI-based Radiomic Features for Risk Stratification of Ductal Carcinoma in Situ in a Multicenter Setting (ECOG-ACRIN E4112 Trial). Radiology. 2025 Apr;315(1):e241628. doi: 10.1148/radiol.241628.
Lehman CD, Gatsonis C, Romanoff J, Khan SA, Carlos R, Solin LJ, Badve S, McCaskill-Stevens W, Corsetti RL, Rahbar H, Spell DW, Blankstein KB, Han LK, Sabol JL, Bumberry JR, Gareen I, Snyder BS, Wagner LI, Miller KD, Sparano JA, Comstock C. Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay With Breast Ductal Carcinoma In Situ Treatment. JAMA Oncol. 2019 Jul 1;5(7):1036-1042. doi: 10.1001/jamaoncol.2018.6269.
Other Identifiers
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NCI-2014-01261
Identifier Type: REGISTRY
Identifier Source: secondary_id
E4112
Identifier Type: OTHER
Identifier Source: secondary_id
ECOG-E4112
Identifier Type: OTHER
Identifier Source: secondary_id
E4112
Identifier Type: -
Identifier Source: org_study_id