Stage IIIA Breast Cancer Clinical Trial
Official title:
Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
RATIONALE: Estrogen and progesterone can stimulate the growth of breast cancer cells.
Hormone therapy using exemestane may fight breast cancer by reducing the production of
estrogen and progesterone. Giving hormone therapy before surgery may shrink the tumor so it
can be removed with breast-conserving surgery. Giving hormone therapy after surgery may kill
any remaining tumor cells.
PURPOSE: Phase II trial to study the effectiveness of neoadjuvant and adjuvant exemestane in
treating postmenopausal women who have locally advancedestrogen and/or progesterone
receptor-positive breast cancer.
OBJECTIVES:
Primary
- Determine the clinical response rate in postmenopausal women with locally advanced
hormone receptor-positive breast cancer treated with neoadjuvant and adjuvant
exemestane.
Secondary
- 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
surgery).
Patients are followed every 3 months for 2 years after surgery and then every 6 months
thereafter.
PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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