Breast cancer
Conditions
Interventions
nab-paclitaxel is administered by drip infusion over 30 minutes in day 1 of 21 days cycle.
Sponsors
Department of Surgical Oncology Osaka City University Graduate School of Medicine
Osaka Breast Cancer Chemo-Endocrine Therapy Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed female breast cancer patients 2) Inoperable or recurrent breast cancer patients 3) Age moer than 20 and less than 80 years old 4) Performance status 0 or 1 (ECOG) 5) Never treated with paclitaxel for metastatic disease. 6) Adequate major organ functions. WBC more than 4000/mm3 and less than 12000/mm3 Neutrophil more than 2000/mm3 Platelet more than 100000/mm3 Hemoglobin more than 9.0 g/dL AST, ALT less than 100 IU/L Total bilirubin less than 1.5 mg/dL Creatinine less than 1.5 mg/dL Normal ECG 7) The patients that an agreement of perticipation was obtained in a document
Exclusion criteria
Exclusion criteria: 1) Past history of hypersensitivity for human serum albumin 2) Infectious disease that required systemic therapy 3) History of a severe heart disease 4) Poorly controlled diabetes mellitus 5) Peptic ulcer or gastrointestinal hemorrhage 6) Symptomatic brain metastsis 7) Pregnant, Lactating or possibility of pregnancy 8) History of drug allergy that may influenced with this treatment 9) In addition, the case that a investigator judged to be inadequate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression Overall response rate Overall survival | — |
Countries
Japan
Contacts
Public ContactTsutomu Takashima
Osaka City University Graduate School of Medicine Department of Surgical Oncology
Outcome results
None listed