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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

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Decision quality, assessed using the composite of knowledge score and decision process score
Factors associated with DCIS score
IBE rate
+9 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
~1160
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Endocrine Therapy
2013
Completed Phase 3
~680
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
119 Previous Clinical Trials
178,679 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
13,842 Previous Clinical Trials
41,002,632 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 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
~90 spots leftby Nov 2027
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