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CREATE-X (JBCRG-04)
GLOBAL This trial is a collaborative study with KBCSG (Korea Breast Cancer Study Group) and KCSG (Korea Cancer Study Group).
Investigation of a capecitabine as a postoperative adjuvant chemotherapy in breast cancer patients who were pathologically confirmed to have residual tumors after preoperative chemotherapy: Phase-III comparative study (Ver. 2.0)
- Status
- Study Closed
- Objectives
- This study is designed to investigate the efficacy and safety of capecitabine, as a postoperative adjuvant chemotherapy, for breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy. In addition, the cost-effectiveness of capecitabine is to be investigated.
- Subjects
- Endpoints
- Primary endpoint: Disease-free survival, Secondary endpoints: Overall survival, Safety, Cost-effectiveness
- Trial Period
- February 2007 - January 2017 (Registration: 5 years, Follow-up study: 5 years)
- Lead Principal Investigator
- Norikazu Masuda (Department of Surgery, Osaka National Hospital)
- Target Sample Size
- 900 (each group consisted of 450 cases)
- Regimen
- AnyPST(+ADR), +/- Xeloda? as ADJ
- Source of Funding
- ACRO: Advanced Clinical Research Organization
- Conference Presentation
- CREATE-X (JBCRG-04): A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X , JBCRG-04) Adjuvant capecitabine in breast cancer patients with pathologic residual disease after neoadjuvant chemotherapy: First safety analysis of CREATE-X (JBCRG-04)
- Articles and Publications
- Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy
- Memo
- COI Disclosure