Breast cancer
Conditions
Interventions
Cyclophosphamide 600mg/m2 day1 Albumin-bound paclitaxel 150mg/m2 - 260mg/m2 day1 every 3 weeks
Sponsors
Shiga University of Medical Science
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histological confirmed primary breast cancer 2) Clinically confirmed metastatic breast cancer 3) Age are 20-70 years old 4) ECOG performance status of 0 or 1 5) no effect remain from prior chemotherapy 6) Required baseline laboratory data(within 14 days of registration) WBC >= 4,000/mm3 Neu >= 2,000/mm3 Hb >= 9.0g/dL Plt >= 100,000/mm3 T-Bil <= 1.5mg/dL AST < 100 IU/L ALT < 100 IU/L Cre <= 1.5mg/dL 7) Expected survival time: more than 3 months 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) allergy of the nab-paclitaxel, paclitaxel or albumin 2) allergy of the medication 3) HER2 positive confirmed by IHC 3+ or FISH+ 4) During pregnancy or lactation 5) Severe infectious disease 6) Clinically significant heart disease 7) Uncontrollable pleural effusion or ascites requiring 8) Symptomatic brain metastasis 9) with active another cancer 10) Peripheral neuropathy grade 2 or greater 11) with pulmonary fibrosis or pneumonitis 12) Cases who physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determinate maximum tolerated dose and recommended dose | — |
Countries
Japan
Outcome results
None listed