Status:

COMPLETED

Protocol for Women at Increased Risk of Developing Breast Cancer

Lead Sponsor:

Carol Fabian, MD

Collaborating Sponsors:

Novartis

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer.

Detailed Description

A pilot study of letrozole in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. Subjects will have hyperplasia with atypia (or borderline Epithelial Hyperpl...

Eligibility Criteria

Inclusion

  • evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast
  • on hormone replacement therapy
  • postmenopausal
  • increased risk of developing breast cancer based on personal or family history
  • never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months
  • women who have a high risk of breast cancer
  • older than 18 years

Exclusion

  • anticoagulants
  • marked breast tenderness
  • pregnant or within twelve months of breast feeding/childbirth

Key Trial Info

Start Date :

January 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2008

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT00291135

Start Date

January 1 2003

End Date

October 1 2008

Last Update

June 15 2016

Active Locations (1)

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1

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160