CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
Telapristone Acetate +5 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/NCT02314156
NCT02314156Phase 2Completed
CompareCT.gov

Intra-mammary Distribution of Transdermal Telapristone Versus Oral Telapristone: A Randomized Window Trial in Women Undergoing Mastectomy

Northwestern University·interventional·Posted Dec 11, 2014·Updated Feb 22, 2023

In Brief

A Phase 2 clinical trial evaluating Telapristone Acetate, Placebo, and 2 other interventions for BRCA1 Mutation Carrier and 8 related conditions. Completed, enrolled 67 participants across 3 sites.

Detailed Summary

This randomized trial studies transdermal or oral telapristone acetate in treating patients undergoing surgery to remove the breast (mastectomy). Telapristone acetate may help prevent breast cancer from forming in premenopausal women. Giving telapristone acetate transdermally may be safer and have fewer side effects than oral administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ductal Breast Carcinoma In Situ, Lobular Breast Carcinoma In Situ, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 11, 2014
Enrollment StartOct 1, 2015
Primary CompletionJan 1, 2018
Study CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.6 years ago

Interventions

Telapristone Acetatedrug

Given transdermally

Placeboother

Given PO

Telapristone Acetatedrug

Given PO

Placeboother

Given transdermally

Laboratory Biomarker Analysisother

Correlative studies

Questionnaire Administrationother

Ancillary studies