At a glance
ClinicalIndex Comparison RecordPhase 3Active· 86 enrolled
Drug / intervention
metformin hydrochloride +1 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.
Testing for Atypia in Random Periareolar Fine Needle Aspiration (RPFNA) Cytology After 12 Months Metformin (1, 1-Dimethylbiguanide Hydrochloride) Chemoprevention Versus Placebo Control in Premenopausal Women
In Brief
A Phase 3 clinical trial evaluating metformin hydrochloride and placebo for Atypical Ductal Breast Hyperplasia and 4 related conditions. Active but no longer recruiting, targeting 86 participants across 27 sites.
Detailed Summary
This randomized phase III trial studies metformin hydrochloride to see how well it works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of metformin hydrochloride may prevent breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtypical Ductal Breast Hyperplasia, BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 3Active
20142015201620172018201920202021202220232024202520262027
First PostedJul 2013
Enrollment StartNov 2015
Primary CompletionNov 2023
TodayJul 2026
Study CompletionNov 2026
First PostedJul 23, 2013
Enrollment StartNov 23, 2015
Primary CompletionNov 10, 2023
Study CompletionNov 1, 2026
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 12.9 years ago
Interventions
metformin hydrochloridedrug
given PO
placeboother
given PO