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Takashi Hojo, Norikazu Masuda, Tomonori Mizutani, Taro Shibata, Takayuki Kinoshita, Kenji Tamura, Fumikata Hara, Tomomi Fujisawa, Kenichi Inoue, Shigehira Saji, Kenichi Nakamura, Haruhiko Fukuda, Hiroji Iwata, Intensive vs. Standard Post-Operative Surveillance in High-Risk Breast Cancer Patients (INSPIRE): Japan Clinical Oncology Group Study JCOG1204, Japanese Journal of Clinical Oncology, Volume 45, Issue 10, October 2015, Pages 983–986, https://doi.org/10.1093/jjco/hyv110
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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.