CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
oral placebo +3 moredrug
Likely dose
afimoxifene 2mgfrom 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/NCT00952731
NCT00952731Phase 2Completed
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Pre-surgical Phase IIb Trial of Transdermal 4-Hydroxytamoxifen vs. Oral Tamoxifen in Women With Ductal Carcinoma in Situ of the Breast

Northwestern University·interventional·Posted Aug 6, 2009·Updated Jul 21, 2015

In Brief

A Phase 2 clinical trial evaluating oral placebo, afimoxifene, and 2 other interventions for Ductal Breast Carcinoma in Situ and Estrogen Receptor-positive Breast Cancer. Completed, enrolled 27 participants across 1 site.

Detailed Summary

This randomized phase II trial is studying 4-hydroxytamoxifen to see how well it works compared with tamoxifen citrate in treating women with newly diagnosed ductal breast carcinoma in situ. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether topical tamoxifen causes less damage to normal tissue than systemic tamoxifen in treating patients with ductal carcinoma in situ.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuctal Breast Carcinoma in Situ, Estrogen Receptor-positive Breast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2009
Enrollment StartDec 1, 2009
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.9 years ago

Interventions

oral placebodrug

Oral placebo taken daily for 4-10 weeks.

afimoxifenedrug

2mg/breast applied daily in the form of a gel for 4-10 weeks.

tamoxifen citratedrug

20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.

placebo geldrug

Placebo gel applied to breasts daily for 4-10 weeks.