Clinical Trials

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)

State
Completed

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

UMIN-ID
UMIN000000843

jRCT

Memo

COI Disclosure

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