Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

Withdrawn

• Conditions: Breast Cancer
• Interventions: Procedure: Fine needle aspiration

• Registration Number: NCT00329017
• Lead Sponsor: Carol Fabian, MD

Brief Summary

A study to examine the potential associations between common single nucleotide polymorphisms and pre-cancerous conditions in breast tissue specimens from postmenopausal women.

Detailed Description

A study to examine the correlation between single nucleotide polymorphisms (SNPs) affecting steroid and carcinogen metabolism and benign breast tissue cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer and taking hormone replacement therapy.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-05-19
• Study First Submitted QC: 2006-05-19
• Study First Posted: 2006-05-24
• Primary Completion: 2015-11-12
• Study Completion: 2015-11-12
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• postmenopausal women on or off hormone replacement therapy
• at high risk of developing breast cancer determined by family or personal history
• postmenopausal women not on hormone replacement therapy for at minimum six months prior to corresponding aspiration
• willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies

Exclusion Criteria

• women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Fine needle aspiration	Post-menopausal women who are at increased risk for development of breast cancer on the basis of family or personal history.

Primary Outcome Measures

Name	Time	Method
Correlation of SNP patterns with cytlomorphology of breast fine needle aspirates.	ongoing	develoment of algorithm for prediction of risk of developing breast cancer.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States