Safety trial of eriburin treatment to patient who has peripheral neuropathy
Phase 2
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000008802
- Lead Sponsor
- Dept of surgical oncology, Hiroshima university hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion Criteria
1)Forbidden case to use eribulin 2)Serious bone marrow suppression 3)Allergy to component of eribulin 4)Pregnant or like be pregnant 5)Serious liver or renal disorder 6)Inadequate interval from prior therapy 7)Symptomatic brain metastasis 8)Patient with CNS disease, DM, RA, or bone metastasis (possible involvement peripheral neropathy) 9)Peripheral neuropathy caused from surgery 10)With doctors decision for exclusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rates of peripheral neuropathy G3(CTCAE)
- Secondary Outcome Measures
Name Time Method Response Rate Overall Survival FACT-NTX EQ-5D Safety PNQ