HER2-negative metastatic breast cancer
Conditions
Interventions
All patients received paclitaxel 90 mg/m2 iv on days 1, 8, and 15 and bevacizumab 10 mg/kg iv on days 1 and 15 in cycles every 28 days.
Sponsors
Hiroshima University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer. (2) Unresectable metastatic breast cancer. (3) With measurable lesions. (4) Female over 20 years old. (5) ECOG PS 0-2. (6) HER2 negative. (7) Taxane-untreated metastatic breast cancer.(Patients who had received taxane-based adjuvant therapy were required to have had a disease-free interval of at least 12 months after completion of taxane therapy.) (8) Sufficient organ function. (Ex. Meeting following criteria.) 1. Neutrophil >=1,500 mm3 2. Platelet >=100,000 mm3 3. AST,ALT <=2.5 x upper limit of normal (ULN) (<=5 x upper limit of normal (ULN) in case of liver metastasis) 4. Serum total bilirubin <=1.5 mg/dL 5. Serum creatinine <=1.5 mg/dL 6. Urine protein <=1+ (9) Signed written informed consent.
Exclusion criteria
Exclusion criteria: (1) Forbidden case to use paclitaxel and bevacizumab. (2) With uncontrollable hypertension. (3) Nonhealing wound. (4) With VTE or PE. (5) With GI perforation or Digestive ulcer. (6) Severe cardiac disease (Ex. Congestive heart failure or coronary artery disease)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Safety, Progression free survival , Overall survival, Time to treatment failure, Disease control rate, QOL | — |
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Countries
Japan
Contacts
Public ContactShinsuke Sasada
Hiroshima Unversity Hospital Breast Surgery
Outcome results
None listed