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Alternative Dosing of Exemestane in Postmenopausal Women with Stage 0-II ER-Positive Breast Cancer: a Randomized Presurgical Trial
Exemestane has been approved as one of the treatments for breast cancer in postmenopausal women. It can be used for women whose breast cancer returns after treatment or as first treatment after surgery. Recently, exemestane has also been studied in healthy postmenopausal women to lower breast cancer risk. As part of this study, participants will receive exemestane, a medication that reduces estrogen levels. It is often taken daily by breast cancer patients after surgical removal of their tumors. The main goal of the study is to test whether giving a lower dose of this drug (by giving it less often than every day) can lower hormone levels as much as giving the drug daily and cause similar changes in breast cancers with fewer side effects.
Primary Objective: It has been shown that exemestane reduces estradiol levels both at the standard dose (25 mg/day) and at lower doses. We expect to achieve with 25 mg three times a week (M/W/F) and 25 mg/week similar effects in estradiol reductions to the standard dose of 25 mg daily. Non-inferiority of percent change in time of serum estradiol levels, adjusted for baseline levels, following four up to six weeks of exemestane 25 mg given three times per week or one time per week compared with exemestane 25 mg daily dosing. Secondary Objectives: - To assess safety and toxicity. - To support the preventive activity of exemestane we will investigate the change in Ki-67 and PgR levels in tumor cells and the adjacent intraepithelial neoplasia or benign histologic structures. - To assess possible association of estradiol level with tissue and circulating biomarkers. - To investigate possible pharmacogenetic markers. - To assess drug levels on tissue samples. - To investigate tissue and circulating proteomics profiling.