Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Hyperplasia

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Letrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Oral Letrozole 2.5 mg daily for six months

letrozole

Carol J Fabian, MD

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.

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

Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.

Novartis

Carol Fabian, MD

Professor, Director Breast Cancer Prevention Unit

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Carol J. Fabian, M.D.

All subjects completed study and were used for analysis

Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Protocol for Women at Increased Risk of Developing Breast Cancer	NCT00291135	Breast Cancer	letrozole	18 Years -	University of Kansas Medical Center
Protocol for Women at Increased Risk of Developing Breast Cancer	NCT00291135	Breast Cancer	letrozole	18 Years -	University of Kansas Medical Center

Spots Global Cancer Trial Database for open label pilot study