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

Healthy Subject Clinical Trial

Official title:

Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03303846
• Other study ID #: 17009
• Secondary ID: NCI-2017-01757U0
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 13, 2017
• Est. completion date: April 25, 2026

Study information

• Verified date: April 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 344
• Est. completion date: April 25, 2026
• Est. primary completion date: April 25, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Procedure:
• Magnetic Resonance Imaging
Undergo high risk breast cancer screening MRI
• Biospecimen Collection
Undergo blood and tissue sample collection

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Ohio State University, Stefanie Spielman Comprehensive Breast Center	Columbus	Ohio
United States	City of Hope Medical Center	Duarte	California
United States	Duke University	Durham	North Carolina
United States	University of Southern California	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predictive accuracy of WNT10B with magnetic resonance imaging (MRI)	The specificity for MRI combined with WNT10B and/or p53 based biomarkers to detect triple negative breast cancer (TNBC) will be calculated with 95% confidence interval (CI). Its prediction accuracy will be described by C-index and compared to that by diagnosis by MRI alone.	Up to 12 months
Primary	Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study	Development of breast cancers other than triple-negative (e.g. estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2) the study analysis, however they will be reported as descriptive statistics.	Up to 12 months
Secondary	Expression of WNT10B/mutant p53 in morphologically normal breast tissue	Biopsy tissue will be assessed for 1) activated WNT10B (measured by presence of high phospho-beta-catenin; present vs. absent) and 2) loss of p53 function (measured by the loss of p21 expression; present versus [vs.] absent). The optimal cut for the WNT10B to differentiate progression vs. non-progression women will be carried out by receiver operating characteristic (ROC) analysis, and hence WNT10B expression will be dichotomized to high vs. low expression. Chi-square test 12-month progression. Adjusted association will be further explored by logistic regression incorporating subject characteristics, such as age, body mass index (BMI), race, and BRCA1.	Up to 12 months