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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF 4-HYDROXYTAMOXIFEN TOPICAL GEL IN WOMEN WITH MAMMOGRAPHICALLY DENSE BREASTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF 4-HYDROXYTAMOXIFEN TOPICAL GEL IN WOMEN WITH MAMMOGRAPHICALLY DENSE BREASTS
4-羟基他莫昔芬外用凝胶对乳房 X 光检查致密乳房女性的随机、双盲、安慰剂对照研究
批准号：
10252736
负责人：
POWEL BROWN
金额：
$9.56万
依托单位：
UNIVERSITY OF TX MD ANDERSON CAN CTR
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
项目状态：
已结题
起止时间：
2016-09-19 至 2021-09-18
来源：
https://reporter.nih.gov/project-details/10252736
关键词：
4-Hydroxy-TamoxifenAftercareAgeAge-YearsBRCA1 geneBiopsyBreastBreast Cancer PreventionClassificationCollagenDoseDouble-Blind MethodFacultyGelGoalsLaboratoriesMammographic DensityMammographyMeasurementMethodsPTGS2 geneParentsPathway interactionsPharmaceutical PreparationsPlacebosQuestionnairesRandomizedRiskSafetySerumStructureSymptomsTamoxifenTerminal Ductal Lobular UnitUniversitiesWisconsinWomanarmbreast densitydensitymembermutation carrierplacebo controlled studyprimary endpointsecondary endpointtissue biomarkerstreatment armtreatment group

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The goal of this solicitation is to develop, conduct and analyze a randomized three-arm breast cancer prevention study among women age 40-50 years of age or <40 years if Gail risk ≥1.66 (including BRCA1/2 mutation carriers) with mammographically dense breasts (BIRADS C or D, according to fifth edition classification) to assess whether daily application of 2 mL or 4 mL of afimoxifene (4-hydroxytamoxifen) gel lowers breast density.
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