CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 208 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Metformin 500mgfrom 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/NCT01589367
NCT01589367Phase 2Completed
CompareCT.gov

Phase II Randomized Study of Neoadjuvant Metformin Plus Letrozole vs Placebo Plus Letrozole for ER-positive Postmenopausal Breast Cancer

Seoul National University Hospital·interventional·Posted May 1, 2012·Updated Sep 10, 2018

In Brief

A Phase 2 clinical trial evaluating Metformin and Placebo for Hormone Receptor Positive Malignant Neoplasm of Breast. Completed, enrolled 208 participants across 1 site.

Detailed Summary

Preoperative letrozole versus letrozole with metformin in postmenopausal Estrogen receptor positive breast cancer patients Phase II multicenter 1:1 randomized clinical trial Total 208 patients Primary endpoint Clinical response rate Secondary endpoint Pathologic complete response rate Breast conserving surgery rate Percent mammographic density change Ki67(%) change after 4week medication of 2nd core needle biopsy Toxicity profile of neoadjuvant letrozole, metformin

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHormone Receptor Positive Malignant Neoplasm of Breast
CountriesSouth Korea
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 1, 2012
Enrollment StartMay 1, 2012
Primary CompletionApr 1, 2018
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 14.2 years ago

Interventions

Metformindrug

Metformin HCl 500mg(morning/evening) PO daily x 1week Metformin HCl 1000mg(morning)and 500mg(evening)PO daily x 1week Metformin HCl 1000mg(morning/evening) PO daily x 22weeks

Placebodrug

Letrozole 2.5mg PO daily + Placebo 1 tablet PO 2/day x 1week Letrozole 2.5mg PO daily + Placebo 2 tablet+ 1 tablet PO x 1 week Letrozole 2.5mg PO daily + Placebo 2 tablet PO 2/day x 22 weeks