Breast Cancer
Conditions
Interventions
bevacizumab 10mg/kg, day 1, 15 paclitaxel 90mg/mm2, day 1, 8, 15 Treatment is administered every 4 weeks until evidence of disease progression, unacceptable toxicity, patient refusal.
Sponsors
Kansai medical university
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed breast cancer 2) Age20=< 3) ECOG performance status of 0 to 2 4) With one or more measurable brain metastasis based on RECIST(1cm=<) 5) No prior Bevacizumab or Paclitaxel 6) Adequate organ function, evaluated within 28 days before enrollment as WBC>=3,000/mm3 Neu>=1,500/mm3 Plt>=75,000/mm3 hemoglobin >=9.0g/dL AST,ALT=<2.5xULN Cr=<ULN Proteinuria<1+ 7) All patients provided written informed consent
Exclusion criteria
Exclusion criteria: 1) Symptomatic brain metastasis 2) Active double cancer 3) Scheduled operation 4) Patients with a history of severe hypersensitivity to drugs used in this trial 5) Uncontrolable hypertension 6) Currently have or have a history of a Ascites ,Pleural effusion or pericardial effusion which requires treatment 7) Problematic infection 8) Uncontrolable complications 9) Sever complications 10) Pregnant or lactation women, or women with known or suspected pregnancy 11) Decision of ineligibility by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate for intracranial metastases | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Overall Response Rate(ORR), Disease Control Rate(DCR), Progression Free Survival(PFS) | — |
Countries
Japan
Outcome results
None listed