|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.|
"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-"
"Patients with advanced and recurrent HER2- negative breast cancer with a history of neoadjuvant or adjuvant therapy with anthracyclines and taxanes without a history of chemotherapy after recurrence. (JBCRG-19)"
"Evaluation of the Usefulness of Pre-operative Exemestane (EXE) Therapy for Treatment of Hormone-Sensitive Breast Cancer in Postmenopausal Patients, and EXE + Low-Dose CPA Combination Therapy for Nonresponders to EXE Therapy."
"Evaluation of the Usefulness of Pre-operative Exemestane (EXE) Therapy for Treatment of Hormone-Sensitive Breast Cancer in Postmenopausal Patients, and EXE + TC Combination Therapy for Nonresponders to EXE Therapy."