Publications
Detailed Information
Phase II randomized trial of neoadjuvant metformin plus letrozole versus placebo plus letrozole for estrogen receptor positive postmenopausal breast cancer (METEOR)
Cited 47 time in
Web of Science
Cited 48 time in Scopus
- Authors
- Issue Date
- 2014-03-10
- Publisher
- BioMed Central Ltd
- Citation
- BMC Cancer Vol.14, pp.1-5
- Keywords
- Metformin ; Letrozole ; Neoadjuvant ; Estrogen receptor-positive Breast cancer
- Description
- This study is being supported by grant no 04-2012-0290 from the SNUH Research fund and by the National Research Foundation of Korea(NRF) grant funded by the Korea government(MSIP)(No. 2013005540).
Letrozole and metformin are being supplied by the pharmaceutical company, Shin Poong Pharm. Co., Ltd.
- Abstract
- Background : Neoadjuvant endocrine therapy with an aromatase inhibitor has shown efficacy comparable to that of neoadjuvant chemotherapy in patients with postmenopausal breast cancer. Preclinical and clinical studies have shown that the antidiabetic drug metformin has anti-tumor activity. This prospective, multicenter, phase II randomized, placebo controlled trial was designed to evaluate the direct anti-tumor effect of metformin in non-diabetic postmenopausal women with estrogen-receptor (ER) positive breast cancer.
Methods/Design : Patients meeting the inclusion criteria and providing written informed consent will be randomized to 24weeks of neoadjuvant treatment with letrozole (2.5mg/day) and either metformin (2000mg/day) or placebo. Target accrual number is 104 patients per arm. The primary endpoint will be clinical response rate, as measured by calipers. Secondary endpoints include pathologic complete response rate, breast conserving rate, change in Ki67 expression, breast density change, and toxicity profile. Molecular assays will be performed using samples obtained before treatment, at week 4, and postoperatively.
Discussion : This study will provide direct evidence of the anti-tumor effect of metformin in non-diabetic, postmenopausal patients with ER-positive breast cancer.
Trial registration : ClinicalTrials.gov Identifier NCT01589367
- ISSN
- 1471-2407
- Language
- English
- Files in This Item:
- Appears in Collections:
Item View & Download Count
Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.