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

The Schema is a timeline of the study. It indicates start/end points, visits expected, major testing to be done, and any other information that is crucial to understanding how the study was completed.



Following informed consent and eligibility confirmation, participants were evaluated at baseline by conducting their physical exam, recording their medical and surgical histories, symptoms, concomitant medications, tobacco/alcohol use, and collection of blood information. MenQoL questionnaire was self administered. Participants were then registered and randomized in one of three arms; receiving exemestane orally daily (QD), QD on days 1, 3 and 5 with placebo on remaining days, or QD on day 1 only with placebo on remaining days. The participants then had telephone monitoring at a week before surgery (+3 days). During a final clinical visit, the day before surgery, participants were given a physical exam, toxicity assessment, concomitant medications, blood collection for clinical lab tests and circulating biomarkers, compliance/review pill diary. MenQoL questionnaire was self administered The blood withdrawn for biomarkers is ideally at 12 hours, 1.5-2.5 days and 5.5-6.5 days from last active dose respectively for arm 1, 2 and 3 depending on scheduled final visit. Participants continue intervention until the night before surgery. At surgery, surgical specimens are collected.