Phase1 Study of nab-paclitaxel plus Cyclophosphamide in Metastatic Breast Cancer
Phase 1
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000009046
- Lead Sponsor
- Sapporo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 12
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method maximum tolerated dose(MTD) and the recommended dose(RD)
- Secondary Outcome Measures
Name Time Method Safety and Response Rate