Phase II study of q3w nab-paclitaxel in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Phase 2
- Conditions
- Metastatic breast cancer
- Registration Number
- JPRN-UMIN000006547
- Lead Sponsor
- Fukushima Medical University School of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1. With history of hypersensitivity reaction for paclitaxel and/or albumin and/or trastuzumab. 2. With severe complications. 3. Pregnant or nursing women. 4. With widespread liver metastases or with dyspnea in pulmonary lymphangitis. 5. With severe complications. 6. With brain metastasis. 7. with uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease. 8. With pulmonary fibrosis or pneumonitis. 9. With dyspnea at rest. 10. With pleural effusion, ascites, pericardial effusion. 11. Doctor's decision not to be registered to this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival Safety Overall survival