Clinical Trials

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.
Memo Collaboration with Korean researchers.
English Protocol has changed to Ver2.4 on April 18,2009.
English Protocol has changed to Ver2.7 on April 1, 2010.
Korean enrollment has finished April 6th, Japan on June 30th.

English Protocol has changed to Ver3.1 on May 30, 2016.

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