Protocol for Women at Increased Risk of Developing Breast Cancer

Study of the Effect of Letrozole on Breast Biomarkers of High Risk Postmenopausal Women Receiving Hormone Replacement Therapy

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.

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 Hyperplasia/Atypical Hyperplasia) and evidence of Estrogen Receptor expression by random periareolar fine needle aspiration and baseline serum estradiol levels less than or equal to 150 pg/ml. The feasibility of performing RT-qPCR on breast specimens for aromatase expression will also be done at baseline.

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