Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.
Completed
- Conditions
- Breast CancerHER2-negative Breast Cancer
- Registration Number
- NCT02371174
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
The primary objective of the study is to clarify factors affecting the incidence of peripheral neuropathy in patients treated with HALAVEN. A total of 590 patients will be enrolled in this study with 295 patients in the treatment group of primary or secondary chemotherapy and 295 patients in the treatment group of tertiary or later chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 651
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with adverse events and serious adverse events Baseline and up to 2 years after the initial dose of HALAVEN Time to resolution of peripheral neuropathy Baseline and up to 2 years after the initial dose of HALAVEN Number of participants with peripheral neuropathy Baseline, and every two months after the initial dose of HALAVEN up to 2 years Common Terminology Criteria for Adverse Events (CTCAE) grade of peripheral neuropathy is assessed at baseline, and every two months after the initial dose of HALAVEN up to 2 years.
Number of participants with adverse drug reactions Baseline and up to 2 years after the initial dose of HALAVEN Time to onset of peripheral neuropathy Baseline and up to 2 years after the initial dose of HALAVEN
- Secondary Outcome Measures
Name Time Method Overall survival Up to 2 years