• Exemestane a basse dosi
• carcinoma mammario

The aromatase inhibitor exemestane (EXE) has shown to lower cancer incidence in high-risk postmenopausal women. However, undesirable symptoms and side effects (i.e., bone density loss, musculoskeletal ache, climacteric syndrome) may compromise patient motivation and adherence to a long-term preventive treatment.
The primary objective in this trial is to assess if the reduction in estradiol with EXE 25 mg/three times a week and EXE 25 mg/week is comparable with the standard dose of 25 mg/day of EXE.
We are conducting a multi-center (Galliera Hospital, IEO, Moffit, MDACC, Columbia) , pre-surgical, double-blind, non-inferiority phase IIb study in which 180 postmenopausal women will be randomized to receive either EXE 25 mg/day or 25 mg/three times a week or 25 mg/week for 4 to 6 weeks prior to surgery. Surgery will occur on day 29, 36 or 43 after treatment initiation. Eligible subjects are postmenopausal women with histologically-confirmed ER-positive (ER >10%) primary breast cancer candidates for surgery. Participants with T0-2, N0-1, Mx or with larger tumors who refuse neo-adjuvant therapy before surgery are eligible. Subjects are stratified according to participating site and body mass index (<25 kg/m2 versus >25 kg/m2). The data studied in this thesis are still blinded. Therefore in this thesis were analysed the typology of adverse effects found during the study and the predictions on the primary endpoint, confirmed when arms will be opened.