title: Intensive vs. Standard Post-Operative Surveillance in High-Risk Breast Cancer Patients (INSPIRE): Japan Clinical Oncology Group Study JCOG1204.
abstract: This Phase III trial aims to determine the superiority of intensive follow-up to standard follow-up in terms of overall survival in high-risk breast cancer patients, who are expected to have recurrence rates of over 30% within 5 years after surgery. Eligible patients are randomized either to the intensive follow-up group or to the standard follow-up group; the former will undergo physical examination, bone scintigraphy, chest computed tomography, abdominal computed tomography, brain magnetic resonance imaging/computed tomography and frequent tumor marker evaluations, whereas the latter will undergo physical examination at the same frequency and tumor markers will be evaluated once a year. Mammography once a year is planned for both groups. The primary endpoint is overall survival. Patient accrual was started in November 2013. A total of 1700 patients will be enrolled for 3 years and followed up for 7 years after closure of accrual. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000012429.
authors.affiliation: Department of Breast Surgery, National Cancer Center, Tokyo tahojo@ncc.go.jp.
authors.forename: Takashi
authors.initials: T
authors.lastname: Hojo
authors.affiliation: Department of Breast Surgery, Osaka National Hospital, Osaka.
authors.forename: Norikazu
authors.initials: N
authors.lastname: Masuda
authors.affiliation: JCOG Data Center, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Mizutani
authors.affiliation: JCOG Data Center, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.affiliation: Department of Breast Surgery, National Cancer Center, Tokyo.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Kinoshita
authors.affiliation: Department of Breast and Medical Oncology, National Cancer Center, Tokyo.
authors.forename: Kenji
authors.initials: K
authors.lastname: Tamura
authors.affiliation: Department of Breast Surgery, Shikoku Cancer Center, Breast and Medical Oncology, Ehime.
authors.forename: Fumikata
authors.initials: F
authors.lastname: Hara
authors.affiliation: Department of Breast Oncology, Gunma Prefectural Cancer Center, Gunma.
authors.forename: Tomomi
authors.initials: T
authors.lastname: Fujisawa
authors.affiliation: Department of Breast Oncology, Saitama Cancer Center, Saitama.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Inoue
authors.affiliation: Department of Medical Oncology, Fukushima Medical University, Fukushima.
authors.forename: Shigehira
authors.initials: S
authors.lastname: Saji
authors.affiliation: JCOG Data Center, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Nakamura
authors.affiliation: JCOG Data Center, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.affiliation: Aichi Cancer Center Hospital, Nagoya, Japan.
authors.forename: Hiroji
authors.initials: H
authors.lastname: Iwata
mesh_terms: D000328:Adult; D000368:Aged; D014408:Biomarkers, Tumor / Q000032:analysis; D001943:Breast Neoplasms / Q000175:diagnosis / Q000401:mortality / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007564:Japan; D008137:Longitudinal Studies; D008279:Magnetic Resonance Imaging; D008327:Mammography; D008495:Medical Oncology / Q000379:methods; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care; D011184:Postoperative Period; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D055815:Young Adult
chemical_list: D014408:Biomarkers, Tumor
keywords: breast surgery; clinical trial-trial design; diagnostic radiology