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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

No Placebo-Only Group

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 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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1180