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

Hormone Receptor Positive Malignant Neoplasm of Breast Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

To identify the anti-tumor effect of metformin with preoperatively given letrozole in postmenopausal estrogen receptor positive breast cancer patients ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01589367
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase Phase 2
Start date May 2012
Completion date August 2018
View Details
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