At a glance
ClinicalIndex Comparison RecordPhase 1Active· 32 enrolled
Drug / intervention
Endoxifen Hydrochloride +2 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.
Phase I Trial of Endoxifen Gel Versus Placebo Gel in Women Undergoing Breast Surgery
In Brief
A Phase 1 clinical trial evaluating Endoxifen Hydrochloride, Placebo Administration, and 1 other intervention for Breast Carcinoma In Situ and 12 related conditions. Active but no longer recruiting, targeting 32 participants across 3 sites.
Detailed Summary
This randomized phase I trial studies the side effects and best dose of endoxifen hydrochloride in treating participants who are undergoing breast surgery. Endoxifen hydrochloride may treat or reduce the risk of breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Carcinoma In Situ, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7
CountriesUnited States
Collaborators--
Timeline
Phase 1Active
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartOct 2018
Primary CompletionFeb 2021
TodayJul 2026
Study CompletionAug 2026
First PostedOct 23, 2017
Enrollment StartOct 31, 2018
Primary CompletionFeb 22, 2021
Study CompletionAug 12, 2026
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.7 years ago
Interventions
Endoxifen Hydrochloridedrug
Apply to the skin
Placebo Administrationother
Apply to the skin
Questionnaire Administrationother
Ancillary studies