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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

Cited 17 time in Web of Science Cited 18 time in Scopus
Authors

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

Issue Date
2016-05
Publisher
BioMed Central
Citation
BMC Cancer, Vol.16, p. 319
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.
ISSN
1471-2407
URI
https://hdl.handle.net/10371/177289
DOI
https://doi.org/10.1186/s12885-016-2354-6
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  • College of Medicine
  • Department of Medicine
Research Area Clinical Medicine

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