|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|
|Articles and Publications|
|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.
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"A randomized, multicenter, phase II trial comparing neo-adjuvant therapy using pertuzumab and trastuzumab emtansine based on the dual HER2 blockade in patients with operable HER2-positive primary breast cancer(Neo-peaks study) "
"Bevacizumab plus paclitaxel optimization study with interventional maintenance endocrine therapy in advanced or metastatic ER-positive HER2-negative breast cancer -BOOSTER trial, a multicenter randomized phase II study-"