Phase II randomized trial of neoadjuvant metformin plus letrozole versus placebo plus letrozole for estrogen receptor positive postmenopausal breast cancer (METEOR)

Jisun Kim, Woosung Lim, Eun Kyu Kim, Min Kyoon Kim, Nam Sun Paik, Sang Seol Jeong, Jung han Yoon, Chan H. Park, Sei H. Ahn, Lee S. Kim, Sehwan Han, Seok J. Nam, Han Sung Kang, Seung I. Kim, Young B. Yoo, Joon Jeong, Tae H. Kim, Taewoo Kang, Sung Won Kim, Yongsik JungJeong E. Lee, Ku S. Kim, Jong Han Yu, Byung J. Chae, So Youn Jung, Eunyoung Kang, Su Y. Choi, Hyeong Gon Moon, Dong Young Noh, Wonshik Han

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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 24 weeks of neoadjuvant treatment with letrozole (2.5 mg/day) and either metformin (2000 mg/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.

Original languageEnglish
Article number170
JournalBMC cancer
Volume14
Issue number1
DOIs
Publication statusPublished - 2014 Mar 10

All Science Journal Classification (ASJC) codes

  • Genetics
  • Oncology
  • Cancer Research

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    Kim, J., Lim, W., Kim, E. K., Kim, M. K., Paik, N. S., Jeong, S. S., Yoon, J. H., Park, C. H., Ahn, S. H., Kim, L. S., Han, S., Nam, S. J., Kang, H. S., Kim, S. I., Yoo, Y. B., Jeong, J., Kim, T. H., Kang, T., Kim, S. W., ... Han, W. (2014). Phase II randomized trial of neoadjuvant metformin plus letrozole versus placebo plus letrozole for estrogen receptor positive postmenopausal breast cancer (METEOR). BMC cancer, 14(1), [170]. https://doi.org/10.1186/1471-2407-14-170