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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
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
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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I am using or will use effective birth control or abstain from sex during the study.
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I have had an MRI and any other necessary tests as indicated.
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My last surgery removed all visible cancer with clear margins, and I have DCIS.
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I have a confirmed diagnosis of ductal carcinoma in situ without invasive disease, diagnosed within the last 4 months.
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I've had a mammogram of both breasts within 6 months and of the affected breast within 3 months.
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I haven't taken hormone therapy for breast cancer prevention in the last 3 months.
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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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I have decided with my doctor if I will have a lumpectomy or mastectomy.
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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 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
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Radiation Therapy
2017
Completed Phase 3
~7250
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9860
Endocrine Therapy
2013
Completed Phase 3
~680

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
115 Previous Clinical Trials
176,454 Total Patients Enrolled
4 Trials studying Breast Cancer
3,528 Patients Enrolled for Breast Cancer
Eastern Cooperative Oncology GroupNETWORK
268 Previous Clinical Trials
150,462 Total Patients Enrolled
31 Trials studying Breast Cancer
45,322 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,278 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 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 C (wide local excision), Arm E (radiation therapy, endocrine therapy), Arm A (MRI), Arm B (mastectomy), Arm D (endocrine therapy)
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
~105 spots leftby Nov 2027