Alternative Dosing of Exemestane in Postmenopausal Women with Stage 0-II ER-Positive Breast Cancer: a Randomized Presurgical Trial

Protocol: 
AAAQ5054
Phase: 
II

Alternative Dosing of Exemestane in Postmenopausal Women with Stage 0-II ER-Positive Breast Cancer: a Randomized Presurgical Trial

This randomized phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing the exemestane standard dose regimen versus two alternative, less frequent dose regimens may decrease undesirable symptoms and be more effective in treating breast cancer.

Are you Eligible? (Inclusion Criteria)

1) Postmenopausal women (* postmenopausal: age >60 years, or amenorrhea >= 12 months, or bilateral oophorectomy, or - in women with hysterectomy only - FSH >30 IU/L if < 60 years old) with histologically-confirmed ER positive (>= 10%) primary breast cancer stage T0-2, N0-1, Mx. Women with larger tumors who refuse chemo and/or endocrine neoadjuvant therapy can be eligible
2) Cannot have BMI < 18.5 Kg/m2
3) No plans to receive neoadjuvant therapy
4) No history of severe osteoporosis (T score < -4 either spine or hip), or presence of vertebral fracture

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States