NCT03303846

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

Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 344 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Healthy Subject

Interventions

Type	Name	Description
PROCEDURE	Magnetic Resonance Imaging	Undergo high risk breast cancer screening MRI
PROCEDURE	Biospecimen Collection	Undergo blood and tissue sample collection
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-10-13
• Primary completion: 2026-04-25
• Completion: 2026-04-25
• First posted: 2017-10-06
• Last updated: 2025-04-11

Locations

5 sites across 1 country: United States