Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology
Overview
- Phase
- N/A
- Intervention
- Magnetic Resonance Imaging
- Conditions
- Healthy Subject
- Sponsor
- City of Hope Medical Center
- Enrollment
- 344
- Locations
- 10
- Primary Endpoint
- Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study
- Status
- Active, Not Recruiting
- Last Updated
- 10 days ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Magnetic Resonance Imaging
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.
Intervention: Biospecimen Collection
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.
Intervention: Laboratory Biomarker Analysis
Outcomes
Primary Outcomes
Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study
Time Frame: Up to 12 months
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.
Secondary Outcomes
- Expression of WNT10B/mutant p53 in morphologically normal breast tissue(Up to 12 months)