Breast cancer
Conditions
Interventions
Gemcitabine:1250mg/m2 day1,8 nab-Paclitaxel:180mg/m2-260mg/m2 day1 every 3 weeks
Sponsors
Okayama Univesity Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histrogical confirmed primary breast cancer 2)Clinically confirmed metastatic breast cancer 3)HER2 negative confirmed by IHC or FISH 4)Age are 20-75 years old 5)None primary treatment with Paclitaxel and Gemcitabine *More than 6 months from Neo-adjuvant or adjuvant chemotherapy by paclitaxel or Gemcitabine 6)Required baseline primary treastment More than 4 weeks from surgery More than 2weeks from radiotherapy or endocrine therapy 7)Performance status of 0 or 1 8)Required baseline laboratory date WBC:4000/mm3-12000/mm3 Neu:>=4000/mm3 Plt:>=100000/mm3 Hb:>=9.0g/dL ALT and AST:<2.5 times of nomal range in institute T-Bil:<=1.5mg/dL Cr:<=1.5mg/dL 9)Expected survival time:more than 3 months 10)Written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determinate maximum tolerated dose and recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To determinate pharmacokinetics of nab-Paclitaxel and to validate feasibility | — |
Countries
Japan
Contacts
Public ContactNaruto Taira
Okayama University Hospital Breast and endocrical surgery
Outcome results
None listed