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.
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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
Аннотация
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.