title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov Identifier NCT00912548 . Registered May 31 2009. Korean Breast Cancer Society Study Group Register KBCSG005 . Registered October 26 2009.
authors.affiliation: Department of Surgery, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Republic of Korea.
authors.forename: Hyun-Ah
authors.initials: HA
authors.lastname: Kim
authors.affiliation: Department of Surgery, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Sei Hyun
authors.initials: SH
authors.lastname: Ahn
authors.affiliation: Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of medicine, Seoul, Republic of Korea.
authors.forename: Seok Jin
authors.initials: SJ
authors.lastname: Nam
authors.affiliation: Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Seho
authors.initials: S
authors.lastname: Park
authors.affiliation: Center for Breast Cancer, National Cancer Center, Goyang, Republic of Korea.
authors.forename: Jungsil
authors.initials: J
authors.lastname: Ro
authors.affiliation: Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: Seock-Ah
authors.initials: SA
authors.lastname: Im
authors.affiliation: Department of Surgery, Ajou University, School of Medicine, Suwon, Republic of Korea.
authors.forename: Yong Sik
authors.initials: YS
authors.lastname: Jung
authors.affiliation: Department of Surgery, Chonnam National University Hwasun Hospital, Gwangju, Republic of Korea.
authors.forename: Jung Han
authors.initials: JH
authors.lastname: Yoon
authors.affiliation: Department of Surgery, Cheil General Hospital and Women's Healthcare Center, Dankook University College of Medicine, Seoul, Republic of Korea.
authors.forename: Min Hee
authors.initials: MH
authors.lastname: Hur
authors.affiliation: Department of Internal Medicine, Korea University Anam Hospital, Seoul, Republic of Korea.
authors.forename: Yoon Ji
authors.initials: YJ
authors.lastname: Choi
authors.affiliation: Department of Surgery, Yeungnam University Hospital, Daegu, Republic of Korea.
authors.forename: Soo-Jung
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: Department of Surgery, Gangnam Severance Hospital, Yonsei University, Seoul, Republic of Korea.
authors.forename: Joon
authors.initials: J
authors.lastname: Jeong
authors.affiliation: Department of Surgery, Dong-A University Hospital, Busan, Republic of Korea.
authors.forename: Se-Heon
authors.initials: SH
authors.lastname: Cho
authors.affiliation: Department of Surgery, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, Republic of Korea.
authors.forename: Sung Yong
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Department of Surgery, Soonchunhyang University Colleage of Medicine, Seoul, Republic of Korea.
authors.forename: Min Hyuk
authors.initials: MH
authors.lastname: Lee
authors.affiliation: Division of Breast & Endocrine Surgery, Hallym University Sacred Heart Hospital, College of Medicine, Hallym University, Anyang, Republic of Korea.
authors.forename: Lee Su
authors.initials: LS
authors.lastname: Kim
authors.affiliation: Department of Surgery, Mokdong Hospital, Ewha Womans University, Seoul, Republic of Korea.
authors.forename: Byung-In
authors.initials: BI
authors.lastname: Moon
authors.affiliation: Department of Surgery, Inje University Busan Paik Hospital, Busan, Republic of Korea.
authors.forename: Tae Hyun
authors.initials: TH
authors.lastname: Kim
authors.affiliation: Department of Surgery, Sungkyunkwan University School of Medicine, Kangbuk Samsung Hospital, Seoul, Republic of Korea.
authors.forename: Chanheun
authors.initials: C
authors.lastname: Park
authors.affiliation: Department of Surgery, Inha University Hospital, Inha University, Incheon, Republic of Korea.
authors.forename: Sei Joong
authors.initials: SJ
authors.lastname: Kim
authors.affiliation: Department of Surgery, Chonbuk National University Medical School, Jeonju, Republic of Korea.
authors.forename: Sung Hoo
authors.initials: SH
authors.lastname: Jung
authors.affiliation: Department of Breast Surgery, Gachon University Gil Hospital, Incheon, Republic of Korea.
authors.forename: Heungkyu
authors.initials: H
authors.lastname: Park
authors.affiliation: Department of Surgery, Inje University Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea.
authors.forename: Geum Hee
authors.initials: GH
authors.lastname: Gwak
authors.affiliation: Department of Surgery, Keimyung University School of Medicine, Daegu, Republic of Korea.
authors.forename: Sun Hee
authors.initials: SH
authors.lastname: Kang
authors.affiliation: Departments of Surgery, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
authors.forename: Jong Gin
authors.initials: JG
authors.lastname: Kim
authors.affiliation: Department of Surgery, Chungnam National University Hospital, Daejeon, Republic of Korea.
authors.forename: Jeryong
authors.initials: J
authors.lastname: Kim
authors.affiliation: Department of Surgery, KangDong sacred heart hospital, Hallym university, Seoul, Republic of Korea.
authors.forename: Su Yun
authors.initials: SY
authors.lastname: Choi
authors.affiliation: Department of Surgery, Soonchunhyang University College of Medicine, Bucheon Hospital, Bucheon, Republic of Korea.
authors.forename: Cheol-Wan
authors.initials: CW
authors.lastname: Lim
authors.affiliation: Department of Surgery, Kangseo Mizmedi Hospital, Seoul, Republic of Korea.
authors.forename: Doyil
authors.initials: D
authors.lastname: Kim
authors.affiliation: Department of Surgery, Konkuk University School of Medicine, Seoul, Republic of Korea.
authors.forename: Youngbum
authors.initials: Y
authors.lastname: Yoo
authors.affiliation: Department of Surgery, Chungbuk National University College of Medicine and Medical Research Institute, Cheongju, Republic of Korea.
authors.forename: Young-Jin
authors.initials: YJ
authors.lastname: Song
authors.affiliation: Department of Surgery, Eulji University Hospital, Daejeon, Republic of Korea.
authors.forename: Yoon-Jung
authors.initials: YJ
authors.lastname: Kang
authors.affiliation: Department of Surgery, Seoul St. Mary's Hospital, Medical College of The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Sang Seol
authors.initials: SS
authors.lastname: Jung
authors.affiliation: Breast and thyroid care center, Department of Surgery, Myongji Hospital, Goyang, Republic of Korea.
authors.forename: Hyuk Jai
authors.initials: HJ
authors.lastname: Shin
authors.affiliation: Department of Surgery, Daejeon St. Mary's Hospital, The Catholic University of Korea, Daejeon, Republic of Korea.
authors.forename: Kwan Ju
authors.initials: KJ
authors.lastname: Lee
authors.affiliation: Department of Surgery, Ajou University, School of Medicine, Suwon, Republic of Korea.
authors.forename: Se-Hwan
authors.initials: SH
authors.lastname: Han
authors.affiliation: Center for Breast Cancer, National Cancer Center, Goyang, Republic of Korea.
authors.forename: Eun Sook
authors.initials: ES
authors.lastname: Lee
authors.affiliation: Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: Wonshik
authors.initials: W
authors.lastname: Han
authors.affiliation: Department of Surgery, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Hee-Jung
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Department of Surgery, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Republic of Korea. nohwoo@kcch.re.kr.
authors.forename: Woo Chul
authors.initials: WC
authors.lastname: Noh
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D005260:Female; D017273:Goserelin / Q000008:administration & dosage; D006801:Humans; D053208:Kaplan-Meier Estimate; D008598:Menstruation; D017697:Premenopause; D013629:Tamoxifen / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D013629:Tamoxifen; D017273:Goserelin
keywords: Adjuvant endocrine therapy; Breast cancer; Goserelin; Ovarian function suppression; Premenopause; Tamoxifen