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, Jeong Joon, Tae H. Kim, Taewoo Kang, Sung Won Kim, Yongsik Jung & 10 others Jeong 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

Research output: Contribution to journalArticle

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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

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letrozole
Metformin
Estrogen Receptors
Placebos
Breast Neoplasms
Neoadjuvant Therapy
Neoplasms
Aromatase Inhibitors
Informed Consent
Hypoglycemic Agents
Breast
Arm
Randomized Controlled Trials
Drug Therapy

All Science Journal Classification (ASJC) codes

  • Oncology
  • Genetics
  • Cancer Research

Cite this

Kim, Jisun ; Lim, Woosung ; Kim, Eun Kyu ; Kim, Min Kyoon ; Paik, Nam Sun ; Jeong, Sang Seol ; Yoon, Jung han ; Park, Chan H. ; Ahn, Sei H. ; Kim, Lee S. ; Han, Sehwan ; Nam, Seok J. ; Kang, Han Sung ; Kim, Seung I. ; Yoo, Young B. ; Joon, Jeong ; Kim, Tae H. ; Kang, Taewoo ; Kim, Sung Won ; Jung, Yongsik ; Lee, Jeong E. ; Kim, Ku S. ; Yu, Jong Han ; Chae, Byung J. ; Jung, So Youn ; Kang, Eunyoung ; Choi, Su Y. ; Moon, Hyeong Gon ; Noh, Dong Young ; Han, Wonshik. / Phase II randomized trial of neoadjuvant metformin plus letrozole versus placebo plus letrozole for estrogen receptor positive postmenopausal breast cancer (METEOR). In: BMC cancer. 2014 ; Vol. 14, No. 1.
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title = "Phase II randomized trial of neoadjuvant metformin plus letrozole versus placebo plus letrozole for estrogen receptor positive postmenopausal breast cancer (METEOR)",
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.",
author = "Jisun Kim and Woosung Lim and Kim, {Eun Kyu} and Kim, {Min Kyoon} and Paik, {Nam Sun} and Jeong, {Sang Seol} and Yoon, {Jung han} and Park, {Chan H.} and Ahn, {Sei H.} and Kim, {Lee S.} and Sehwan Han and Nam, {Seok J.} and Kang, {Han Sung} and Kim, {Seung I.} and Yoo, {Young B.} and Jeong Joon and Kim, {Tae H.} and Taewoo Kang and Kim, {Sung Won} and Yongsik Jung and Lee, {Jeong E.} and Kim, {Ku S.} and Yu, {Jong Han} and Chae, {Byung J.} and Jung, {So Youn} and Eunyoung Kang and Choi, {Su Y.} and Moon, {Hyeong Gon} and Noh, {Dong Young} and Wonshik Han",
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Kim, J, Lim, W, Kim, EK, Kim, MK, Paik, NS, Jeong, SS, Yoon, JH, Park, CH, Ahn, SH, Kim, LS, Han, S, Nam, SJ, Kang, HS, Kim, SI, Yoo, YB, Joon, J, Kim, TH, Kang, T, Kim, SW, Jung, Y, Lee, JE, Kim, KS, Yu, JH, Chae, BJ, Jung, SY, Kang, E, Choi, SY, Moon, HG, Noh, DY & 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, vol. 14, no. 1, 170. https://doi.org/10.1186/1471-2407-14-170

Phase II randomized trial of neoadjuvant metformin plus letrozole versus placebo plus letrozole for estrogen receptor positive postmenopausal breast cancer (METEOR). / Kim, Jisun; Lim, Woosung; Kim, Eun Kyu; Kim, Min Kyoon; Paik, Nam Sun; Jeong, Sang Seol; Yoon, Jung han; Park, Chan H.; Ahn, Sei H.; Kim, Lee S.; Han, Sehwan; Nam, Seok J.; Kang, Han Sung; Kim, Seung I.; Yoo, Young B.; Joon, Jeong; Kim, Tae H.; Kang, Taewoo; Kim, Sung Won; Jung, Yongsik; Lee, Jeong E.; Kim, Ku S.; Yu, Jong Han; Chae, Byung J.; Jung, So Youn; Kang, Eunyoung; Choi, Su Y.; Moon, Hyeong Gon; Noh, Dong Young; Han, Wonshik.

In: BMC cancer, Vol. 14, No. 1, 170, 10.03.2014.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II randomized trial of neoadjuvant metformin plus letrozole versus placebo plus letrozole for estrogen receptor positive postmenopausal breast cancer (METEOR)

AU - Kim, Jisun

AU - Lim, Woosung

AU - Kim, Eun Kyu

AU - Kim, Min Kyoon

AU - Paik, Nam Sun

AU - Jeong, Sang Seol

AU - Yoon, Jung han

AU - Park, Chan H.

AU - Ahn, Sei H.

AU - Kim, Lee S.

AU - Han, Sehwan

AU - Nam, Seok J.

AU - Kang, Han Sung

AU - Kim, Seung I.

AU - Yoo, Young B.

AU - Joon, Jeong

AU - Kim, Tae H.

AU - Kang, Taewoo

AU - Kim, Sung Won

AU - Jung, Yongsik

AU - Lee, Jeong E.

AU - Kim, Ku S.

AU - Yu, Jong Han

AU - Chae, Byung J.

AU - Jung, So Youn

AU - Kang, Eunyoung

AU - Choi, Su Y.

AU - Moon, Hyeong Gon

AU - Noh, Dong Young

AU - Han, Wonshik

PY - 2014/3/10

Y1 - 2014/3/10

N2 - 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.

AB - 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.

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U2 - 10.1186/1471-2407-14-170

DO - 10.1186/1471-2407-14-170

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