|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.|
|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
|No. of Institutions|
|Target Sample Size||750（cohort A:500, cohort B:250）|
|Regimen||bevacizumab combined with paclitaxel|
|Source of Funding||Chugai Pharmaceutical Co., Ltd.|
|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||Protocol was revised to ver1.1 on Oct.3,2016|
"A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Locally Advanced and Metastatic Breast Cancer（Study of Perjeta re-treatment for clinical outcomes）"
"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) "
"Phase III study evaluating palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in patients with hormone-receptor-positive, HER2-normal primary breast cancer with high relapse risk after neoadjuvant chemotherapy“PENELOPEB”"
"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-"