Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-13

Study Completion Date

2026-04-25

Brief Summary

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This clinical trial studies normal breast tissue changes combined with breast magnetic resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast tissue markers in combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years.

SECONDARY OBJECTIVES:

I. To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts women with an abnormal MRI/non-cancerous biopsy who will progress to cancer over 7 years.

TERTIARY OBJECTIVES:

I. To determine the predictive accuracy of WNT10B with MRI, of which will be compared with MRI alone using the C-index.

OUTLINE:

Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants undergo collection of breast tissue samples at any breast biopsy or breast surgery.

Conditions

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Healthy Subject

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Treatment (breast MRI, biopsy)

Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants also undergo collection of breast tissue samples at any breast biopsy or breast surgery.

Group Type EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo high risk breast cancer screening MRI

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood and tissue sample collection

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Magnetic Resonance Imaging

Undergo high risk breast cancer screening MRI

Intervention Type PROCEDURE

Biospecimen Collection

Undergo blood and tissue sample collection

Intervention Type PROCEDURE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Magnetic Resonance / Nuclear Magnetic Resonance MRI NMR Imaging NMRI Nuclear Magnetic Resonance Imaging

Eligibility Criteria

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Inclusion Criteria

* Women who are undergoing screening breast MRI as per standard of care for high-risk breast cancer screening
* Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast surgery
* Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn
* Documented informed consent of the participant

Exclusion Criteria

* Allergy or intolerance to gadolinium
* Inability to undergo breast MRI (e.g. claustrophobia)
* Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ)
* Previous diagnosis of stage 4 cancer
* Participants who have received cytotoxic chemotherapy within 1 year prior to screening breast MRI
* Participants who have received endocrine therapy within 1 year prior to screening breast MRI
* Participants who have received breast radiation within 1 year prior to screening breast MRI
* Radiation to both breasts
* Pregnant and/or lactating within 1 year prior to screening breast MRI
* Receives screening breast MRIs at an outside facility other than the consenting institution

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes