Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
- Determine the clinical response rate in postmenopausal women with locally advanced
hormone receptor-positive breast cancer treated with neoadjuvant and adjuvant
- Determine the response rate by mammography, ultrasound, MRI, and positron emission
tomography scan in patients treated with this drug.
- Determine the time to progression in patients treated with this drug.
- Compare the expression of hormone receptors and epidermal growth factor receptors
(including HER2/neu) in patients prior to and after treatment with this drug and
correlate these results with clinical response rates.
OUTLINE: Patients receive oral exemestane once daily for 16 weeks in the absence of disease
progression or unacceptable toxicity. After 16 weeks, patients undergo surgery and then
continue exemestane once daily for a total of 5 years (including the 16 weeks before
Patients are followed every 3 months for 2 years after surgery and then every 6 months
PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
William John Gradishar, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|