Clinical Trials

JBCRG04(CREATE-X)
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)

State No longer recruiting
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.
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)
No. of Institutions 85 (Target number)
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 2013 SABCS poster, 2015 SABCS Oral
Articles and Publications 2017 NEJM
UMIN-ID UMIN000000843
  UMIN-ID : This clinical trial is registered in UMIN-CTR (Medical Information, University hospital Medical Information Network - Clinical Trials Registry). Please search for this trial by UMIN-ID in the following URL.
  http://www.umin.ac.jp/ctr/index-j.htm
Memo

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