Randomized phase II study of eribulin versus nab-paclitaxel in patients with relapsed HER2-negative breast cancer previously treated with anthracycline and peri-operative taxane
Phase 2
- Conditions
- Breast Cancer relapsed after surgery
- Registration Number
- JPRN-UMIN000008839
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 140
Inclusion Criteria
Not provided
Exclusion Criteria
1) prior eribulin and/or nab-paclitaxel 2) taxane for metastatic disease 3) <6monthd from last taxane administration 4) Effusions (pleural, pericardial effusion, ascites) requiring treatment 5) brain metastasis requiring treatment 6) >=grade 2 peripheral sensory neuropathy (CTCAE ver4.0) 7) clinically abnormal ECG 8) systemic infection 9) severe diabetes mellitus 10) interstitial pneumonia/pulmonary fibrosis apparent on chest Xp 11) active double cancer 12) severe psychosis 13) systemic corticosteroid 14) severe drug allergy 15) hypersensitivity for paclitaxel and/or albumin 16) positive HBs antigen 17) pregnant or lactating woman 18) other causes judged ineligible by attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method