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Ductal Breast Carcinoma In SituNCT02352883

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

A study testing Magnetic Resonance Imaging, Therapeutic Conventional Surgery and Therapeutic Surgical Procedure in people with Ductal Breast Carcinoma In Situ, run by ECOG-ACRIN Cancer Research Group at 76 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ductal Breast Carcinoma In Situ
What is being tested?
Magnetic Resonance Imaging, Therapeutic Conventional Surgery and Therapeutic Surgical Procedure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
368 participants
Where
76 sitesUnited States
Study dates
25 Mar 2015to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 30Show fewer
  • 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)

Who cannot join

None listed.

Trial locations and contacts

76 sites in 1 country.

76 sites in 1 country

United States76 sites

  • Cancer Care of Western North Carolina

    Asheville, North Carolina, 28801

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

  • John Fitzgerald Kennedy Medical Center

    Atlantis, Florida, 33462

  • IU Health West Hospital

    Avon, Indiana, 46123

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Medical Oncology LLC

    Baton Rouge, Louisiana, 70809

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Northwestern University

    Chicago, Illinois, 60611

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Easton Hospital

    Easton, Pennsylvania, 18042

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Greenwich Hospital

    Greenwich, Connecticut, 06830

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Midstate Medical Center

    Meriden, Connecticut, 06451

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Memorial Regional Cancer Center Day Road

    Mishawaka, Indiana, 46544

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

    Mount Holly, New Jersey, 08060

  • Edward Hospital/Cancer Center

    Naperville, Illinois, 60540

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Regional Hematology and Oncology PA

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Oconomowoc Memorial Hospital-ProHealth Care Inc

    Oconomowoc, Wisconsin, 53066

  • Owensboro Health Mitchell Memorial Cancer Center

    Owensboro, Kentucky, 42303

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Phoenixville Hospital

    Phoenixville, Pennsylvania, 19460

  • Edward Hospital/Cancer Center?Plainfield

    Plainfield, Illinois, 60585

  • Pottstown Memorial Medical Center

    Pottstown, Pennsylvania, 19464

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92069

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

    Seattle, Washington, 98109

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467-2490

  • Virtua West Jersey Hospital Voorhees

    Voorhees Township, New Jersey, 08043

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Main Office

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17405

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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.

  1. 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.

Being tested
Magnetic Resonance Imaging, Therapeutic Conventional Surgery, Therapeutic Surgical Procedure, Radiation Therapy, Endocrine Therapy
Medical subject headings
Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging Scan, MRI, MRI Scan, NMRI

    Undergo MRI

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo mastectomy

  • Therapeutic Surgical ProcedureProcedure or surgery

    Undergo wide local excision

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation

    Undergo radiation therapy

  • Endocrine TherapyDrug

    Also called Chemotherapy-Hormones/Steroids, Hormonal Therapy, Hormone Therapy

    Undergo endocrine therapy

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Cytology Specimen Collection ProcedureOther

    Also called Cytologic Sampling

    Correlative studies

Study groups in NCT02352883
Study groupRoleWhat they receive
Arm A (MRI)ExperimentalPatients undergo MRI prior to surgery. Patients undergo additional imaging and/or biopsies if indicated based on MRI.
Receives: Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure
Arm B (mastectomy)ExperimentalPatients undergo a mastectomy. Patients do not register for Step 3.
Receives: Procedure: Therapeutic Conventional Surgery; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure
Arm C (wide local excision)ExperimentalPatients 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.
Receives: Procedure: Therapeutic Surgical Procedure; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure
Arm D (endocrine therapy)ExperimentalPatients undergo endocrine therapy as directed.
Receives: Drug: Endocrine Therapy; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure
Arm E (radiation therapy, endocrine therapy)ExperimentalPatients undergo radiation therapy and endocrine therapy as directed.
Receives: Radiation: Radiation Therapy; Drug: Endocrine Therapy; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients judged to be breast conservation candidates based upon standard imaging and physical examination who convert to mastectomy in step 1 based on MRI findings

    Measured: After MRI (within 30 days following study entry), and prior to surgery

  2. Proportion of patients judged to be breast conservation candidates based upon standard imaging and physical examination who have a mastectomy as the final surgical procedure in step 2

    Measured: Up to 12 months post-op

Secondary outcomes (14)

  1. Factors associated with DCIS score

    The relation between baseline clinical covariates (tumor grade, necrosis, histologic type, mammographic lesion size), MRI morphologic and kinetic features, and the DCIS score will be assessed.

    Measured: After surgery (DCIS Score is determined from surgical specimen)

  2. Diagnostic accuracy of MRI in extent of disease evaluation in patients with DCIS

    Measured: Up to 12 months post-op

  3. Proportion of patients who require re-operation because of inadequate excision after MRI

    A two-sided 95% Wilson confidence interval will be derived.

    Measured: Up to 12 months post-op

  4. Proportion of patients who proceed to mastectomy after an initial attempt at wide local excision because of either inadequate tumor-free margins (< 2mm), or other reasons

    A two-sided 95% Wilson confidence interval will be derived. In addition to the overall probability of conversion in this cohort, estimates will be stratified by the reason for conversion.

    Measured: Up to 12 months post-op

  5. IBE rate

    Kaplan-Meier curves will be derived for the time to ipsilateral breast event for patients assigned to be treated with RT and those not treated with RT. Point estimates and 95% two-sided confidence intervals will be developed.

    Measured: At 5 years

  6. IBE rate

    Kaplan-Meier curves will be derived for the time to ipsilateral breast event for patients assigned to be treated with RT and those not treated with RT. Point estimates and 95% two-sided confidence intervals will be developed.

    Measured: At 10 years

  7. Proportion of women who receive treatment that is concordant with their treatment goals and concerns

    The proportion of patients with concordant care will be calculated and a 95% Wilson confidence interval will also be derived.

    Measured: Up to 24 months post-op

  8. Proportion of women whose decision autonomy preference was concordant with perceived level of decision involvement

    Concordance will be defined as an exact match between decision autonomy preference (patient-based, shared, surgeon-based) and perceived level of decision involvement (patient based, shared, surgeon-based) as assessed by the Control Preferences Scale, reduced to three categories. The proportion of patients with concordance will be calculated for the sample. In addition, the degree of concordance over the group will be determined using kappa analysis.

    Measured: Up to 5 days after pre-surgical consultation

  9. Decision quality, assessed using the composite of knowledge score and decision process score

    To calculate knowledge score, a point for each correct answer on the knowledge questionnaire will be assigned, with missing responses receiving 0 points. A total score will be calculated for all patients who complete at least half of the items and scaled from 0-100%. To calculate a decision process score, a point will be assigned for each "yes" or "a lot/some" response. The sum will be scaled from 0-100%. The average of the two scores will be used as the outcome measure.

    Measured: Up to 5 days after pre-surgical consultation

  10. Role of concordance between decision autonomy preference and perceived level of decision involvement, knowledge and decision process scores as independent predictors of decision satisfaction

    Linear regression modeling will be used in which the response variable will be decision satisfaction. The independent variables will be the indicator of concordance between decision autonomy preference and perceived level of decision involvement, the knowledge score and the decision process score. Two-way interactions between predictors will also be examined.

    Measured: Assessed via questionnaire administered at first post-operative visit

  11. Patient-reported quality of life, measured using the Patient Reported Outcomes Measurement Information System (PROMIS)10 instrument

    The relationship of patient-reported outcomes and disease specific covariates, and quality of life will be assessed.

    Measured: At 12 months post-op

  12. Patient-reported quality of life, measured using the PROMIS10 instrument

    The relationship of patient-reported outcomes and disease specific covariates, and quality of life will be assessed.

    Measured: At 24 months post-op

  13. Role of disease status, diagnostic test results, and surgeon recommendation as predictors of treatment received

    Logistic regression modeling will be used in which the response variable will be the indicator of conversion to mastectomy (vs lumpectomy). The independent variables will include covariates describing disease status at baseline, MRI results, surgeon recommendation, patient decision involvement (such as the decision autonomy preference scale) and treatment concerns (as measured via the 7-item questionnaire). Separate analyses will be performed for conversion to mastectomy directly post MRI and conversion to mastectomy following BCS as the response variable.

    Measured: Up to 24 months post-op

  14. Patient-reported diagnostic testing burden of bilateral mammogram, MRI, and biopsies, measured by TMI

    A Wilcoxon signed rank test will be used to compare TMI scores for mammography and MRI. In a secondary analysis regression modeling will be used to examine the effects of patient characteristics on the patient's perception of diagnostic test burden for the two modalities.

    Measured: Up to 5 days after pre-surgical consultation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2015 (estimated)
  2. Study start25 Mar 2015
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02352883
Sponsor's protocol ID
E4112
Other IDs
NCI-2014-01261, E4112, ECOG-E4112, UG1CA189828, U10CA037403
Status last verified
Dec 2025
First submitted
16 Jan 2015
Last updated
19 Dec 2025
Results posted
No

Publications

  • 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 Dec 1;11(12):1507-1511. doi: 10.1001/jamaoncol.2025.4079.

    PubMed 41100122

  • 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.

    PubMed 40608342

  • 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.

    PubMed 40167440

  • 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.

    PubMed 30653209

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Resonance Imaging, Therapeutic Conventional Surgery and Therapeutic Surgical Procedure in people with Ductal Breast Carcinoma In Situ, run by ECOG-ACRIN Cancer Research Group at 76 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients judged to be breast conservation candidates based upon standard imaging and physical examination who convert to mastectomy in step 1 based on MRI findings (time frame: After MRI (within 30 days following study entry), and prior to surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02352883, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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