Breast cancer
Conditions
Interventions
Nab-paclitaxel is 100 mg/m2 administered weekly intravenously over 30 minutes
Sponsors
Wakayama Medical University
Minami Wakayama Medical Center Hashimoto Municipal Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed primary breast cancer 2) Clinically confirmed metastatic breast cancer 3) With measurable lesion 4) Received no previous chemotherapy, or only two regimen 5) Age >= 20 years 6) ECOG performance status of 0 or 1 7) Required baseline laboratory parameters (within 14 days before registration) Hb >= 9.0g/dL WBC >= 4,000/mm3 Neu >= 2,000/mm3 Plt >= 10.0x104/mm3 T-Bil <= 1.5mg/dL AST <= 100 IU/L ALT <= 100 IU/L Cre <= 1.5mg/dL 8) A life expectancy of more than 90 days 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Allergy of nab-paclitaxel, albumin or paclitaxel 2) Serious complication 3) Synchronous or metachronous (within 5 years) double cancers 4) Abnormal ECG 5) Congestive heart failure, coronary artery diseases, uncontrollable arrhythmia or past history of myocardial infarction or angina pectoris within 6 months 6) Relapsed within 12 months (or during its treatment) after taxane-based neoadjuvant and adjuvant chemotherapy. Resistant to taxane-based neoadjuvant chemotherapy 7) Fully recovered from surgical within 4 weeks before registration 8) Received radiotherapy or neoadjuvant and adjuvant chemotherapy within 3 weeks before registration 9) Received endocrine therapy within 2 weeks before registration 10) Received ratiotherapy for more than 30% of hematopoietic bone marrow 11) Peripheral neuropathy grade 2 or greater 12) Active infection 13) Symptomatic brain metastasis 14) Un-controlled pleural effusion and ascites 15) Long-term corticosteroid therapy 16) Mental disorder 17) Pregnancy, breast feeding or wish of future bearing 18) Patients considered inappropriate by the study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event | — |
Countries
Japan
Outcome results
None listed