Feasibility study of weekly nanoparticle albumin-bound paclitaxel for patients with metastatic breast cancer (HBCC1101)
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000007029
- Lead Sponsor
- Hokkaido Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 40
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse drug reaction
- Secondary Outcome Measures
Name Time Method