Breast Cancer
Conditions
Interventions
Nab-paclitaxel 100mg/m2 on days 1, 8, 15
Sponsors
Hokkaido Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histological and/or cytological confirmed breast cancer 2) Metastatic breast cancer 3) Prior chemotherapy is up to 2 regimen 4) Women aged 20 and over 5) HER2 negative by IHC or FISH 6) ECOG performance status: 0-2 7) Adequate organ function 8) Expected survival longer than 90 days 9) Written informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Anamnesis of hypersensitivity to nab-paclitaxel, paclitaxel or albumin 2. Serious complication 3. Active double cancer 4. ECG abnormalities or heart failure with clinically problem 5. Recurrence under taxane treatment or within 12 months from last taxane dosage and progression under taxane treatment 6. Influence of an operation conducted within 4 weeks before registration is carried over 7. Use of radiation or pre-and/or post-surgical cytotoxic drug within 3weeks before registration 8. Use of hormonal drug within 2 weeks before registration 9. Past radiotherapy more than 30% of hematopoietic bone marrow 10. Peripheral neuropathy greater than grade 2 11. Active infectious disease which needs systemic treatment 12. Brain metastasis with symptom or brain metastasis needs medical treatment 13. Storage of pericardium liquid or storage of pleural effusion or ascites which needs drainage 14. Use of steroid regularly 15. Psychologic diseases and/or psychological symptoms 16. With pregnancy, lactation or the possibility of pregnancy 17. Use of investigational new drug within 4 weeks before registration 18. Unsuitable judgement by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse drug reaction | — |
Countries
Japan
Contacts
Public ContactMasato Takahashi
Hokkaido Cancer Center Breast Surgery
Outcome results
None listed