NCT01589367View on ClinicalTrials.gov

Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

April 30, 2018

Study Completion Date

August 31, 2018

Conditions
Hormone Receptor Positive Malignant Neoplasm of Breast
Interventions
DRUG

Metformin

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

DRUG

Placebo

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

Trial Locations (1)

110-744

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

Seoul National University Hospital

OTHER

NCT01589367 - Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer | Biotech Hunter | Biotech Hunter