CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Afimoxifene +4 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.

Search/NCT02993159
NCT02993159Phase 2Completed
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Phase IIB Pre-Surgical Trial of Oral Tamoxifen Versus Transdermal 4-hydroxytamoxifen in Women With DCIS of the Breast

Northwestern University·interventional·Posted Dec 15, 2016·Updated Dec 18, 2024

In Brief

A Phase 2 clinical trial evaluating Afimoxifene, Laboratory Biomarker Analysis, and 2 other interventions for Ductal Breast Carcinoma In Situ and Estrogen Receptor Positive. Completed, enrolled 100 participants across 6 sites.

Detailed Summary

This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuctal Breast Carcinoma In Situ, Estrogen Receptor Positive
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), BHR Pharma, LLC

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 15, 2016
Enrollment StartMay 31, 2017
Primary CompletionMar 30, 2021
Study CompletionJan 24, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.5 years ago

Interventions

Afimoxifenedrug

Applied to the breast

Laboratory Biomarker Analysisother

Correlative studies

Placeboother

Given PO

Placeboother

Applied to the breast

Tamoxifen Citratedrug

Given PO