Clinical Trials

JBCRG-C05

Cohort study evaluating efficacy of bevacizumab plus paclitaxel in patients with HER2-negative inoperable or metastatic breast cancer(JBCRG-C05)

Status
Study Closed

Objectives
The purpose of this study is to evaluate the efficacy and safety of bevacizumab combined with paclitaxel as first or second line chemotherapy in clinical practice in HER2 negative inoperable or metastatic breast cancer patients.

Subjects

Endpoints
Primary outcomes: Overall Survival(OS) Secondary outcomes: Response Rate(RR), Progression Free Survival(PFS), Safety

Trial Period
5 years 2012.11.1 - 2017.10.31

Lead Principal Investigator
1)Yutaka Yamamoto,Kumamoto University Hospital 2)Hiroyasu Yamashiro, National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Target Sample Size
750(cohort A:500, cohort B:250)

Regimen
bevacizumab combined with paclitaxel

Source of Funding
Chugai Pharmaceutical Co., Ltd.

Conference Presentation
Pooled-analysis of prospective observational studies evaluated the effectiveness and safety of bevacizumab and paclitaxel as the first-line chemotherapy for HER2-negative metastatic breast cancer Prospective observational cohort study of bevacizumab combined with paclitaxel as the first- or second-line chemotherapy for locally advanced or metastatic breast cancer (Study JBCRG-C05: B-SHARE) Prospective observational cohort study of bevacizumab combined with paclitaxel as the first- or second-line chemotherapy for locally advanced or metastatic breast cancer (Study JBCRG-C05: B-SHARE)

Articles and Publications
Factors affecting prognosis in patients treated with bevacizumab plus paclitaxel as first-line chemotherapy for HER2-negative metastatic breast cancer: an international pooled analysis of individual patient data from four prospective observational studies Breast Cancer Prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the JBCRG-C05 (B-SHARE) study

UMIN-ID
UMIN000009086

jRCT

Memo

COI Disclosure

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