Clinical trial NCT00291096: High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer
Official title: High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: breast atypia
fine needle aspiration
high risk for breast cancer
breast epithelial hyperplasia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2006-02-13
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Self-identified women at high risk for development of breast cancer

Brief summary: The overall goal of this project is to develop an integrative system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarkers which may be useful in predicting and monitoring response to prevention interventions.

Detailed description: 1. To correlate established risk biomarkers such as cytomorphology obtained from random periareolar fine needle aspiration ( RPFNA), mammographic breast density, serum bioavailable estradiol and IGF-1/IGFBP-3 with each other and with 5-10 year Gail risk estimates. Where available, and with appropriate safe guards to maintain status for breast cancer susceptibility genes may be included.
2. To determine the relative predictive value of established risk biomarkers for the development of DCIS and/or invasive cancer.
3. To evaluate potential new breast tissue-based biomarkers including Ki-67, PCNA, ER, COX-2, aromatase, methylation of key tumor suppressor genes (i.e., RAR, p16, etc), proteomic patterns in RPFNA and nipple aspirate fluid (NAF), as well as NAF hormone levels, and correlate them with other risk biomarkers listed in 1.
4. To determine the prevalence of polymorphisms of a panel of genes important in hormone and xenobiotic metabolism as well as DNA repair and correlate these polymorphisms with established risk biomarkers listed in 1, as well as with development of DCIS and invasive cancer.
5. To maintain contact with this initially identified cohort of high risk women, acquire demographic data, biologic specimens and data and follow them prospectively for the development.

Eligibility criteria: Inclusion Criteria:

* women with at least 2 times the normal risk of developing breast cancer
* between the ages of 30-65 (or within 10 years of youngest age at diagnosis in first degree relative)
* greater than six months from ingestion of antihormonal therapy
* greater than 1 year from pregnancy, lactation, or chemotherapy
* willing to have a mammogram within six months prior to RPFNA
* willing to discontinue NSAIDS or herbal supplements
* willing to have blood drawn

Exclusion Criteria:

* no metastatic malignancy of any kind
* no breast implants or tram flap reconstructions
* no radiation to both breasts
* no women who have a current mammogram or clinical breast exam suspicious for cancer

Primary outcomes:
measure: Prediction of risk for developing breast cancer
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol J Fabian, MD
role: PRINCIPAL_INVESTIGATOR
References: