Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Carol Fabian, MD
With
Novartis
National Cancer Institute (NCI)
Subsequent to the 6 month RPFNA for assessment of biomarkers, toxicity and quality of life assessments, all women may receive optional open-label letrozole for an additional 6 months, followed by a third RPFNA and biomarker
Age
30–69
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Post-menopausal women at high risk for development of breast cancer
stable dose of hormone replacement therapy
have cytomorphologic evidence of hyperplasia +/- atypia and Ki-67 expression \>1.5% in benign breast epithelial cells acquired by RPFNA
Serum level of 25-hydroxyvitamin D of at least 30 ng/ml prior to study entry
Willing to have a repeat random periareolar fine needle aspiration (RPFNA) and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug
You may not be if
Prior history of osteoporosis or osteoporotic fracture.
Prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.
Current and chronic use of cyclooxygenase-2 (COX-2) specific inhibitors or NSAIDs
Receiving treatment for rheumatoid arthritis or fibromyalgia
Current history of poorly controlled migraines or perimenopausal symptoms
Currently receiving other investigational agents.
Receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past.
Clareo Health | Study of Breast Cancer Prevention by Letrozole in High Risk Women
