Recruiting

High Risk Breast Cancer

Sponsor:

New York Presbyterian Hospital

Code:

NCT01034891

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is to increase understanding of women who are at high risk for developing breast cancer. Data from this group will be collected and entered into a registry. This registry serves as a clinical database to support research in prevention, early detection and treatment of breast cancer.

Conditions

Breast Cancer

Study ID

NCT01034891

Start date

Jan, 1991

Status verified date

Oct, 2009

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • one or more first-degree relatives (mother, daughter, or sister) with pre-menopausal breast cancer
  • two or more first-degree relatives with post-menopausal breast cancer
  • tested positive for a BRCA1 or BRCA2 mutation
  • a history of biopsy-proven atypical ductal hyperplasia or atypical lobular hyperplasia
  • a history of biopsy-proven lobular neoplasia (lobular carcinoma in situ)

Exclusion Criteria:

  • DCIS (ductal carcinoma in situ)
  • previous diagnosis of breast cancer

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Amy C Whiffen, MPH

212-305-3238awhiffen@womenatrisknyc.org

Lisa Held, BA

212-305-3269lheld@womenatrisknyc.org

Locations

Women At Risk, Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Amy C Whiffen, MPH

212-305-3238awhiffen@womenatrisknyc.org

Women At Risk, Weill Cornell

Recruiting

New York, New York, United States, 10065

Contacts

Rhonda Theodore

212-821-0635rtm9001@nyp.org

More Information

Sponsor

New York Presbyterian Hospital

Last update posted

Dec 18, 2009

Last verified

Oct, 2009

Keywords

  • BRCA mutation
  • benign breast disease
  • family history of breast cancer
  • strong family history of breast cancer
  • atypical ductal hyperplasia
  • atypical lobular hyperplasia
  • high risk for breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Presbyterian Hospital on 2009-12-18.