Conditions: Breast Cancer
Keywords: breast atypia open label pilot study letrozole fine needle aspiration high risk for breast cancer breast epithelial hyperplasia Ki-67 hormones plus chemoprevention chemoprevention
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 42
Healthy volunteers: no

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 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.

Arms:
arm 1: Oral Letrozole 2.5 mg daily for six months

Interventions: intervention 1: letrozole
Intervention descriptions: intervention 1: Letrozole 2.5 mg daily

Protocol document: