A phase II study of Bevacizumab plus Paclitaxel followed by Eribulin maintenance therapy in patients with HER2-negative metastatic breast cancer.
- Conditions
- HER2-negative metastatic breast cancer
- Registration Number
- JPRN-UMIN000015971
- Lead Sponsor
- Sairtama Breast Cancer Clinical Study Group (SBCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 51
Not provided
1)having systemic infection with a fever of 38 degrees or more 2)protocol treatment of drug, and a history of hypersensitivity to the solvent 3)patients with brain metastases in need of treatment to the brain hypertension and emergency brain radiation 4)patients with following serious complication ischaemic heart disease or heart disease such as arrhythmia not controllable by treatment myocardial infarction < 6 months prior to study entry hepatic cirrhosis interstitial pneumonia or pulmonary fibrosis bleeding tendency Uncontrolable hypertension Uncontrolable proteinuria 5)having active double cancer 6)patients with a history of radiation therapy to the measurable lesions 7)history of mental disorder, a central nervous system damage, and cerebral blood vessel neuropathy 8)pregnancy, breast-feeding or women with childbearing potential 9)patients undergoing continuous systemic administration of steroids 10)HBs antigen is positive 11)judged by the investigator not to be appropriate for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Treament Failure
- Secondary Outcome Measures
Name Time Method Progression Free Survival/ Objective Response Rate/ Overall Survival/ Safety/ FACT-GOG-NTX