Breast Cancer
Conditions
Interventions
nab-paclitaxel 180mg/m2-220mg/m2 Day1 cyclophosphamide 600mg/m2 Day1
Sponsors
Sapporo Medical University
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 1 regimen 4. HER2 negative by IHC or FISH 5. ECOG performance status: 0-1 6. No clinical abnormality by electrocardiography. 7. Adequate organ function 8. Women aged 20 and over 9. Expected survival longer than 3 months 10. Written informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Patients with any history of serious drug reactions 2. Anamnesis of hypersensitivity to nab-paclitaxel and Cyclophosphamide 3. Active double cancer 4. Use of radiation or pre-and/or post-surgical cytotoxic drug within 3weeks before registration 5. Past radiotherapy more than 30% of hematopoietic bone marrow 6. Patients with serious complications 7. Serious peripheral neuropathy 8. Brain metastasis with symptom or brain metastasis needs medical treatment 9. Storage of pericardium liquid or storage of pleural effusion or ascites which needs drainage 10. With pregnancy, lactation or the possibility of pregnancy 11. Unsuitable judgement by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose(MTD) and the recommended dose(RD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Response Rate | — |
Countries
Japan
Contacts
Public ContactGoro Kutomi
Sapporo Medical University First Department of Surgery
Outcome results
None listed