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

City of Hope

Status: Active, not recruiting

Conditions: Healthy Subject

Treatments: Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03303846

17009

U01CA189283 (U.S. NIH Grant/Contract)

NCI-2017-01757 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 344 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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344 participants in 1 patient group

Treatment (breast MRI, biopsy)

Experimental group

Description:

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.

Treatment:

Procedure: Biospecimen Collection

Procedure: Magnetic Resonance Imaging

Other: Laboratory Biomarker Analysis