Metastatic breast cancer
Conditions
Interventions
Abraxane: 260mg/m2, iv, day 1 Every 3 weeks Trastuzumab: 6mg/kg, iv, day1 Every 3 weeks
Sponsors
Fukushima Medical University School of medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed metastatic breast cancer. 2. Age are more than 20 years old 3. within withiin 2 prior treatment for metastatic breast cancer. 4. With evaluable leasion 5. Performance statu is 0,1,2. 6. Required baseline laboratory data. (within 14 days of registration) WBC > 4,000 /mm3 or Neu > 2,000/mm3 PLT > 100,000 /mm3 Hb > 9.0 g/dL ALT and AST < ULNx2.5 ALT and AST < ULNx2.5 T-Bil < 1.5mg/dL serum creatine < 1.5mg/dL 7. Expected survival time: more than 6 months. 8.Written informed- consent
Exclusion criteria
Exclusion criteria: 1. With history of hypersensitivity reaction for paclitaxel and/or albumin and/or trastuzumab. 2. With severe complications. 3. Pregnant or nursing women. 4. With widespread liver metastases or with dyspnea in pulmonary lymphangitis. 5. With severe complications. 6. With brain metastasis. 7. with uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease. 8. With pulmonary fibrosis or pneumonitis. 9. With dyspnea at rest. 10. With pleural effusion, ascites, pericardial effusion. 11. Doctor's decision not to be registered to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Safety Overall survival | — |
Countries
Japan
Contacts
Public ContactTohru Ohtake
Fukushima Medical University School of medicine Department of Surgery, Division of Breast Surgery
Outcome results
None listed