HER2-positive Metastatic breast cancer
Conditions
Interventions
Abraxane: 260mg/m2, iv, day 1 Trastuzumab: 4mg/kg(loading dose) and then 2mg/kg, iv, day 1, 8, 15 or 8mg/kg(loading dose) and then 6mg/kg, iv, day 1, Every 3 weeks
Sponsors
Kumamoto Breast Cancer Cooperative Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed breast cancer with metastatic disease 2. Age are 20-75 years old 3. HER2 Overexpression (IHC3+) or HER2 gene amplification (FISH+) 4. No prior treatment with paclitaxel for metastatic breast cancer 5. with evaluable lesion 6. Performance status:0,1,2 7. LVEF>50% 8. Required baseline laboratory data(within 14 days of registration) WBC >4,000 /mm3 or Neut >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 creatin< 1.5mg/dL 9. Expected survival time: more than 3 months 10. Written informed consent
Exclusion criteria
Exclusion criteria: (1)With history of hypersensitivity reaction for trastuzumab, paclitaxel and albumin (2)With severe complication. (3)Pregnant or nursing women. (4)With widespread liver metastases or pulmonary lymphangitis with dyspnea (5) with active another cancer (6)with brain metastasis with symptom (7)with uncontrollable hypertension, angina pectoris, congestive heart failure, myocardial infection within 1 year, arrhythmia that need treat, valvular heart disease. (8)with pulmonary fibrosis or pneumonitis. (9)with dyspnea at rest (due to metastatic lung lesion and cardiovascular disease). (10)with pleural effusion, ascites, and pericardial effusion that need treat (11) Cases who physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Safety | — |
Countries
Japan
Contacts
Public ContactYutaka Yamamoto
Kumamoto University, Graduate School of Medical Sciences Department of Breast and Endocrine Surgery
Outcome results
None listed