INTRA- MAMMARY DISTRIBUTION OF TRANSERMAL TELAPRISTONE VERSUS ORAL TELAPRISTONE VERSUS ORAL TELAPRISTONE: A RANDOMIZED WINDOW TRAIL IN WOMEN UNDERGOING MASTECTOMY 08/26/2014 -02/25/2017

拟议的临床试验应解决局部药物用于乳腺癌预防的一个主要问题——药物在整个乳房的分布。目的是确定口服和局部给药是否在整个乳房组织中有相似的替拉匹司酮浓度。

The proposed clinical trial shall address a major question in the use of topical agents for breast cancer prevention – drug distribution throughout the breast. The goal is to determine if there are similar breast tissue concentrations of telapristone throughout the breast with both oral and topical delivery. It is a phase IIb randomized double-blinded trial of oral vs. topical telapristone for 4 weeks prior to surgery in women undergoing mastectomy for stage 0-II breast cancer therapy or prophylaxis (for BRCA mutation, BRCA mutation carriers, women with strong family history or lobular carcinoma in situ or other conditions where prophylactic mastectomy has been elected) at Northwestern University, University of Chicago, and Memorial Sloan Kettering Cancer Center.