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Endocrine Therapy

Diagnostic MRI + Gene Expression for Breast Cancer

N/A

Waitlist Available

Led By Constance Lehman

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have known deleterious mutations in breast cancer (BRCA) genes

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 10 years

Awards & highlights

Study Summary

This trial looks at using MRI and gene expression to diagnose patients with abnormal cells in the breast duct. It may help doctors predict a patient's response to treatment and help plan the best treatment.

Who is the study for?

This trial is for women with a confirmed diagnosis of ductal carcinoma in situ (DCIS) of the breast, who have not had invasive breast cancer or DCIS before, and haven't received chemotherapy or hormonal therapy recently. They must be able to undergo MRI with contrast and are considering surgical options like lumpectomy or mastectomy. Participants should not be pregnant, breastfeeding, or planning to become pregnant.Check my eligibility

What is being tested?

The study is examining if combining MRI scans with gene expression analysis can improve diagnosis and treatment planning for patients with DCIS. It aims to see whether these methods can predict treatment response and recurrence risk better than current practices.See study design

What are the potential side effects?

Potential side effects may include reactions to the MRI contrast agent gadolinium such as nausea, headache, pain at injection site; risks associated with biopsies like bleeding and infection; discomfort from mammograms; and general risks of surgery if applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have harmful BRCA gene mutations.

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My last surgery removed all visible cancer with clear margins, and I have DCIS.

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I haven't had chemotherapy for any cancer in the last 6 months.

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I have never had breast radiotherapy that would stop me from getting it now for DCIS.

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I can safely have an MRI with gadolinium contrast.

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I am eligible for a lumpectomy based on my exams and scans.

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My OncotypeDX DCIS Score report for breast cancer has been uploaded.

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I have never had invasive breast cancer or DCIS on the same side before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

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

Factors associated with DCIS score

+10 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Arm E (radiation therapy, endocrine therapy)Experimental Treatment4 Interventions

Patients undergo radiation therapy and endocrine therapy as directed.

Group II: Arm D (endocrine therapy)Experimental Treatment4 Interventions

Patients undergo endocrine therapy as directed.

Group III: Arm C (wide local excision)Experimental Treatment4 Interventions

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.

Group IV: Arm B (mastectomy)Experimental Treatment4 Interventions

Patients undergo a mastectomy. Patients do not register for Step 3.

Group V: Arm A (MRI)Experimental Treatment4 Interventions

Patients undergo MRI prior to surgery. Patients undergo additional imaging and/or biopsies if indicated based on MRI.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endocrine Therapy

2013

Completed Phase 3

~680

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,554 Total Patients Enrolled

4 Trials studying Breast Cancer

3,528 Patients Enrolled for Breast Cancer

Eastern Cooperative Oncology GroupNETWORK

268 Previous Clinical Trials

151,227 Total Patients Enrolled

31 Trials studying Breast Cancer

46,087 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,003 Total Patients Enrolled

941 Trials studying Breast Cancer

1,543,396 Patients Enrolled for Breast Cancer

Media Library

Endocrine Therapy (Endocrine Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02352883 — N/A

Breast Cancer Research Study Groups: Arm B (mastectomy), Arm A (MRI), Arm D (endocrine therapy), Arm E (radiation therapy, endocrine therapy), Arm C (wide local excision)

Breast Cancer Clinical Trial 2023: Endocrine Therapy Highlights & Side Effects. Trial Name: NCT02352883 — N/A

Endocrine Therapy (Endocrine Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02352883 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for individuals to participate in this research?

"As of June 8th 2022, clinicaltrials.gov indicates that this research is not actively recruiting subjects for the trial which commenced on July 1st 2015. There are a total of 4605 other studies seeking enrollees at present, however."

Answered by AI

Are there a plethora of Canadian medical centers executing this experiment?

"Phoenixville Hospital in Phoenixville, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium in Seattle, The Hospital of Central Connecticut in New Britain, and a multitude of other medical facilities across the country are offering this trial."

Answered by AI

Recent research and studies

JAMA OncologyJournal

Association of Magnetic Resonance Imaging and a 12-gene Expression Assay with Breast Ductal Carcinoma in Situ Treatment

Lehman, Constance D., Constantine Gatsonis, Justin Romanoff, Seema A. Khan, Ruth Carlos, Lawrence J. Solin, Sunil Badve, et al.. 2019. “Association of Magnetic Resonance Imaging and a 12-gene Expression Assay with Breast Ductal Carcinoma in Situ Treatment”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2018.6269.

clinicaltrials.govStudy

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

2015. "MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02352883.