High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00291096

Enrollment

3000

Registered

2006-02-13

Start date

1989-08-31

Completion date

2027-12-31

Last updated

2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast atypia, fine needle aspiration, high risk for breast cancer, breast epithelial hyperplasia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Prediction of risk for developing breast cancer	ongoing	development of algorithm for predicting risk for developing breast cancer based on random sampling of benign breast tissue.

Countries

United States

Contacts

Primary ContactBruce Kimler, Ph.D.

bkimler@kumc.edu913-588-4523

Outcome results