Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000009067
- Lead Sponsor
- Okayama Univesity Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 9
Not provided
1)Allergy of the Gemcitabine or nab-Paclitaxel 2)Contraindication to treatment with Gemcitabine or nab-Paclitaxel 3)With sever complications ex.)with incontrollable diabetes,with infection,mental disorder which become problem on clinical practice 4)During pregnancy or lactation 5)With extensive liver metastases, or lymphatic vessel-related metastases to lung with dyspnea 6)With active double cancer 7)With symptomatic brain cancer 8)HBs antigen is positive 9)With uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease 10)With pulmonary fibrosis or pneumonitis 11)With dyspnea at rest 12)With uncontrolled pleural effusion, peritoneal effusion, pericardial effusion 13)With grade 2 or grater peripheral neuropathy 14)Patients judged by the investigator as unfit to be enrolled in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determinate maximum tolerated dose and recommended dose
- Secondary Outcome Measures
Name Time Method To determinate pharmacokinetics of nab-Paclitaxel and to validate feasibility