Protocol for Women at Increased Risk of Developing Breast Cancer

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carol Fabian, MD
• Collaborator: Novartis
• Treatments: Letrozole

Criteria

Inclusion Criteria:

• 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 Criteria:

• anticoagulants

• marked breast tenderness

• pregnant or within twelve months of breast feeding/childbirth