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

经乳房替拉司酮与口服替拉司酮与口服替拉司酮的乳房内分布：接受乳房切除术的女性的随机窗口轨迹 08/26/2014 -02/25/2017

• 批准号: 8948683
• 负责人: RAYMOND BERGAN
• 金额: $ 83.23万
• 依托单位: NORTHWESTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-26 至 2017-02-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8948683
• 关键词: Address; Aftercare; Apoptosis; Breast; Breast Cancer Prevention; Cell Proliferation; Chicago; Clinical Trials; Core Biopsy; Diagnostic; Double-Blind Method; Family; Gel; Gene Expression; Goals; Label; Malignant Neoplasms; Mammary Gland Parenchyma; Mammary gland; Mastectomy; Measures; Memorial Sloan-Kettering Cancer Center; Mutation; Operative Surgical Procedures; Oral; Oral Administration; Phase; Plasma; Progesterone; Progesterone Receptors; Prophylactic treatment; Protein Isoforms; Randomized; Recording of previous events; Research; Safety; Sampling; Serum; Staging; TNFSF10 gene; Tissue Sample; Topical agent; Transdermal substance administration; Universities; Variant; Woman; cancer therapy; caspase-3; drug distribution; indexing; lobular breast carcinoma in situ; malignant breast neoplasm; mutation carrier; prophylactic; protein expression

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.

拟议的临床试验应解决使用局部药物预防乳腺癌的一个主要问题-药物在整个乳房中的分布。目的是确定口服和局部给药在整个乳房中是否存在相似的特拉司酮乳腺组织浓度。 这是一项IIb期随机双盲试验，在接受乳房切除术治疗或预防0-II期乳腺癌的女性中进行术前4周口服与外用特拉司酮的比较（对于BRCA突变、BRCA突变携带者、有强烈家族史或小叶原位癌或其他已选择预防性乳房切除术的情况的女性），西北大学、芝加哥，纪念斯隆凯特琳癌症中心