The role of the addition of ovarian suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or regain menstruation after chemotherapy (ASTRRA): Study protocol for a randomized controlled trial and progress

Hyun Ah Kim, Sei Hyun Ahn, Seok Jin Nam, Seho Park, Jungsil Ro, Seock Ah Im, Yong Sik Jung, Jung Han Yoon, Min Hee Hur, Yoon Ji Choi, Soo Jung Lee, Joon Jeong, Se Heon Cho, Sung Yong Kim, Min Hyuk Lee, Lee Su Kim, Byung In Moon, Tae Hyun Kim, Chanheun Park, Sei Joong KimSung Hoo Jung, Heungkyu Park, Geum Hee Gwak, Sun Hee Kang, Jong Gin Kim, Jeryong Kim, Su Yun Choi, Cheol Wan Lim, Doyil Kim, Youngbum Yoo, Young Jin Song, Yoon Jung Kang, Sang Seol Jung, Hyuk Jai Shin, Kwan Ju Lee, Se Hwan Han, Eun Sook Lee, Wonshik Han, Hee Jung Kim, Woo Chul Noh

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: Ovarian function suppression (OFS) has been shown to be effective as adjuvant endocrine therapy in premenopausal women with hormone receptor-positive breast cancer. However, it is currently unclear if addition of OFS to standard tamoxifen therapy after completion of adjuvant chemotherapy results in a survival benefit. In 2008, the Korean Breast Cancer Society Study Group initiated the ASTRRA randomized phase III trial to evaluate the efficacy of OFS in addition to standard tamoxifen treatment in hormone receptor-positive breast cancer patients who remain or regain premenopausal status after chemotherapy. Methods: Premenopausal women with estrogen receptor-positive breast cancer treated with definitive surgery were enrolled after completion of neoadjuvant or adjuvant chemotherapy. Ovarian function was assessed at the time of enrollment and every 6 months for 2 years by follicular-stimulating hormone levels and bleeding history. If ovarian function was confirmed as premenopausal status, the patient was randomized to receive 2 years of goserelin plus 5 years of tamoxifen treatment or 5 years of tamoxifen alone. The primary end point will be the comparison of the 5-year disease-free survival rates between the OFS and tamoxifen alone groups. Patient recruitment was finished on March 2014 with the inclusion of a total of 1483 patients. The interim analysis will be performed at the time of the observation of the 187th event. Discussion: This study will provide evidence of the benefit of OFS plus tamoxifen compared with tamoxifen only in premenopausal patients with estrogen receptor-positive breast cancer treated with chemotherapy. Trial registration: ClinicalTrials.gov Identifier NCT00912548. Registered May 31 2009. Korean Breast Cancer Society Study Group Register KBCSG005. Registered October 26 2009.

Original languageEnglish
Article number319
JournalBMC Cancer
Volume16
Issue number1
DOIs
Publication statusPublished - 2016 May 19

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Menstruation
Tamoxifen
Randomized Controlled Trials
Hormones
Breast Neoplasms
Drug Therapy
Adjuvant Chemotherapy
Estrogen Receptors
Goserelin
Therapeutics
Patient Selection
Disease-Free Survival
Survival Rate
Observation
Hemorrhage
Survival

Keywords

  • Adjuvant endocrine therapy
  • Breast cancer
  • Goserelin
  • Ovarian function suppression
  • Premenopause
  • Tamoxifen

ASJC Scopus subject areas

  • Oncology
  • Genetics
  • Cancer Research

Cite this

The role of the addition of ovarian suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or regain menstruation after chemotherapy (ASTRRA) : Study protocol for a randomized controlled trial and progress. / Kim, Hyun Ah; Ahn, Sei Hyun; Nam, Seok Jin; Park, Seho; Ro, Jungsil; Im, Seock Ah; Jung, Yong Sik; Yoon, Jung Han; Hur, Min Hee; Choi, Yoon Ji; Lee, Soo Jung; Jeong, Joon; Cho, Se Heon; Kim, Sung Yong; Lee, Min Hyuk; Kim, Lee Su; Moon, Byung In; Kim, Tae Hyun; Park, Chanheun; Kim, Sei Joong; Jung, Sung Hoo; Park, Heungkyu; Gwak, Geum Hee; Kang, Sun Hee; Kim, Jong Gin; Kim, Jeryong; Choi, Su Yun; Lim, Cheol Wan; Kim, Doyil; Yoo, Youngbum; Song, Young Jin; Kang, Yoon Jung; Jung, Sang Seol; Shin, Hyuk Jai; Lee, Kwan Ju; Han, Se Hwan; Lee, Eun Sook; Han, Wonshik; Kim, Hee Jung; Noh, Woo Chul.

In: BMC Cancer, Vol. 16, No. 1, 319, 19.05.2016.

Research output: Contribution to journalArticle

Kim, HA, Ahn, SH, Nam, SJ, Park, S, Ro, J, Im, SA, Jung, YS, Yoon, JH, Hur, MH, Choi, YJ, Lee, SJ, Jeong, J, Cho, SH, Kim, SY, Lee, MH, Kim, LS, Moon, BI, Kim, TH, Park, C, Kim, SJ, Jung, SH, Park, H, Gwak, GH, Kang, SH, Kim, JG, Kim, J, Choi, SY, Lim, CW, Kim, D, Yoo, Y, Song, YJ, Kang, YJ, Jung, SS, Shin, HJ, Lee, KJ, Han, SH, Lee, ES, Han, W, Kim, HJ & Noh, WC 2016, 'The role of the addition of ovarian suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or regain menstruation after chemotherapy (ASTRRA): Study protocol for a randomized controlled trial and progress', BMC Cancer, vol. 16, no. 1, 319. https://doi.org/10.1186/s12885-016-2354-6
Kim, Hyun Ah ; Ahn, Sei Hyun ; Nam, Seok Jin ; Park, Seho ; Ro, Jungsil ; Im, Seock Ah ; Jung, Yong Sik ; Yoon, Jung Han ; Hur, Min Hee ; Choi, Yoon Ji ; Lee, Soo Jung ; Jeong, Joon ; Cho, Se Heon ; Kim, Sung Yong ; Lee, Min Hyuk ; Kim, Lee Su ; Moon, Byung In ; Kim, Tae Hyun ; Park, Chanheun ; Kim, Sei Joong ; Jung, Sung Hoo ; Park, Heungkyu ; Gwak, Geum Hee ; Kang, Sun Hee ; Kim, Jong Gin ; Kim, Jeryong ; Choi, Su Yun ; Lim, Cheol Wan ; Kim, Doyil ; Yoo, Youngbum ; Song, Young Jin ; Kang, Yoon Jung ; Jung, Sang Seol ; Shin, Hyuk Jai ; Lee, Kwan Ju ; Han, Se Hwan ; Lee, Eun Sook ; Han, Wonshik ; Kim, Hee Jung ; Noh, Woo Chul. / The role of the addition of ovarian suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or regain menstruation after chemotherapy (ASTRRA) : Study protocol for a randomized controlled trial and progress. In: BMC Cancer. 2016 ; Vol. 16, No. 1.
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abstract = "Background: Ovarian function suppression (OFS) has been shown to be effective as adjuvant endocrine therapy in premenopausal women with hormone receptor-positive breast cancer. However, it is currently unclear if addition of OFS to standard tamoxifen therapy after completion of adjuvant chemotherapy results in a survival benefit. In 2008, the Korean Breast Cancer Society Study Group initiated the ASTRRA randomized phase III trial to evaluate the efficacy of OFS in addition to standard tamoxifen treatment in hormone receptor-positive breast cancer patients who remain or regain premenopausal status after chemotherapy. Methods: Premenopausal women with estrogen receptor-positive breast cancer treated with definitive surgery were enrolled after completion of neoadjuvant or adjuvant chemotherapy. Ovarian function was assessed at the time of enrollment and every 6 months for 2 years by follicular-stimulating hormone levels and bleeding history. If ovarian function was confirmed as premenopausal status, the patient was randomized to receive 2 years of goserelin plus 5 years of tamoxifen treatment or 5 years of tamoxifen alone. The primary end point will be the comparison of the 5-year disease-free survival rates between the OFS and tamoxifen alone groups. Patient recruitment was finished on March 2014 with the inclusion of a total of 1483 patients. The interim analysis will be performed at the time of the observation of the 187th event. Discussion: This study will provide evidence of the benefit of OFS plus tamoxifen compared with tamoxifen only in premenopausal patients with estrogen receptor-positive breast cancer treated with chemotherapy. Trial registration: ClinicalTrials.gov Identifier NCT00912548. Registered May 31 2009. Korean Breast Cancer Society Study Group Register KBCSG005. Registered October 26 2009.",
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author = "Kim, {Hyun Ah} and Ahn, {Sei Hyun} and Nam, {Seok Jin} and Seho Park and Jungsil Ro and Im, {Seock Ah} and Jung, {Yong Sik} and Yoon, {Jung Han} and Hur, {Min Hee} and Choi, {Yoon Ji} and Lee, {Soo Jung} and Joon Jeong and Cho, {Se Heon} and Kim, {Sung Yong} and Lee, {Min Hyuk} and Kim, {Lee Su} and Moon, {Byung In} and Kim, {Tae Hyun} and Chanheun Park and Kim, {Sei Joong} and Jung, {Sung Hoo} and Heungkyu Park and Gwak, {Geum Hee} and Kang, {Sun Hee} and Kim, {Jong Gin} and Jeryong Kim and Choi, {Su Yun} and Lim, {Cheol Wan} and Doyil Kim and Youngbum Yoo and Song, {Young Jin} and Kang, {Yoon Jung} and Jung, {Sang Seol} and Shin, {Hyuk Jai} and Lee, {Kwan Ju} and Han, {Se Hwan} and Lee, {Eun Sook} and Wonshik Han and Kim, {Hee Jung} and Noh, {Woo Chul}",
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AU - Kim, Hyun Ah

AU - Ahn, Sei Hyun

AU - Nam, Seok Jin

AU - Park, Seho

AU - Ro, Jungsil

AU - Im, Seock Ah

AU - Jung, Yong Sik

AU - Yoon, Jung Han

AU - Hur, Min Hee

AU - Choi, Yoon Ji

AU - Lee, Soo Jung

AU - Jeong, Joon

AU - Cho, Se Heon

AU - Kim, Sung Yong

AU - Lee, Min Hyuk

AU - Kim, Lee Su

AU - Moon, Byung In

AU - Kim, Tae Hyun

AU - Park, Chanheun

AU - Kim, Sei Joong

AU - Jung, Sung Hoo

AU - Park, Heungkyu

AU - Gwak, Geum Hee

AU - Kang, Sun Hee

AU - Kim, Jong Gin

AU - Kim, Jeryong

AU - Choi, Su Yun

AU - Lim, Cheol Wan

AU - Kim, Doyil

AU - Yoo, Youngbum

AU - Song, Young Jin

AU - Kang, Yoon Jung

AU - Jung, Sang Seol

AU - Shin, Hyuk Jai

AU - Lee, Kwan Ju

AU - Han, Se Hwan

AU - Lee, Eun Sook

AU - Han, Wonshik

AU - Kim, Hee Jung

AU - Noh, Woo Chul

PY - 2016/5/19

Y1 - 2016/5/19

N2 - Background: Ovarian function suppression (OFS) has been shown to be effective as adjuvant endocrine therapy in premenopausal women with hormone receptor-positive breast cancer. However, it is currently unclear if addition of OFS to standard tamoxifen therapy after completion of adjuvant chemotherapy results in a survival benefit. In 2008, the Korean Breast Cancer Society Study Group initiated the ASTRRA randomized phase III trial to evaluate the efficacy of OFS in addition to standard tamoxifen treatment in hormone receptor-positive breast cancer patients who remain or regain premenopausal status after chemotherapy. Methods: Premenopausal women with estrogen receptor-positive breast cancer treated with definitive surgery were enrolled after completion of neoadjuvant or adjuvant chemotherapy. Ovarian function was assessed at the time of enrollment and every 6 months for 2 years by follicular-stimulating hormone levels and bleeding history. If ovarian function was confirmed as premenopausal status, the patient was randomized to receive 2 years of goserelin plus 5 years of tamoxifen treatment or 5 years of tamoxifen alone. The primary end point will be the comparison of the 5-year disease-free survival rates between the OFS and tamoxifen alone groups. Patient recruitment was finished on March 2014 with the inclusion of a total of 1483 patients. The interim analysis will be performed at the time of the observation of the 187th event. Discussion: This study will provide evidence of the benefit of OFS plus tamoxifen compared with tamoxifen only in premenopausal patients with estrogen receptor-positive breast cancer treated with chemotherapy. Trial registration: ClinicalTrials.gov Identifier NCT00912548. Registered May 31 2009. Korean Breast Cancer Society Study Group Register KBCSG005. Registered October 26 2009.

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KW - Adjuvant endocrine therapy

KW - Breast cancer

KW - Goserelin

KW - Ovarian function suppression

KW - Premenopause

KW - Tamoxifen

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