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 Kim, Sung 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, 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 Kim, Sung 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

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.

Keywords: Adjuvant endocrine therapy; Breast cancer; Goserelin; Ovarian function suppression; Premenopause; Tamoxifen.

Figures

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Study design

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Source: PubMed

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