At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 194 enrolled
Drug / intervention
Afimoxifene +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Study of 4-hydroxytamoxifen Topical Gel in Women With Mammographically Dense Breast
In Brief
A Phase 2 clinical trial evaluating Afimoxifene, Laboratory Biomarker Analysis, and 2 other interventions for Mammographically Dense Breast. Completed, enrolled 194 participants across 5 sites.
Detailed Summary
This randomized phase II trial studies how well afimoxifene works in reducing the risk of breast cancer in women with mammographically dense breast. Estrogen can cause the growth of breast cancer cells. Hormone therapy using afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMammographically Dense Breast
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 2017
Enrollment StartJan 2018
Primary CompletionOct 2021
TodayJul 2026
First PostedFeb 24, 2017
Enrollment StartJan 30, 2018
Primary CompletionOct 26, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9.4 years ago
Interventions
Afimoxifenedrug
Applied topically
Laboratory Biomarker Analysisother
Correlative studies
Placeboother
Applied topically
Questionnaire Administrationother
Ancillary studies