Healthy Subject
Conditions
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.
Interventions
PROCEDUREMagnetic Resonance Imaging
Undergo high risk breast cancer screening MRI
PROCEDUREBiospecimen Collection
Undergo blood and tissue sample collection
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study | 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
| Measure | Time frame | Description |
|---|---|---|
| Expression of WNT10B/mutant p53 in morphologically normal breast tissue | Up to 12 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVictoria Seewaldt, MD
City of Hope Medical Center
Outcome results
None listed