Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.

Study Overview
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Brief Summary
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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.

Official Title
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An Observational Post-Marketing Surveillance Study on the Status and Factors for the Development of Peripheral Neuropathy in Patients With HER2-Negative Inoperable or Recurrent Breast Cancer in Japan.

Conditions
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Breast Cancer, HER2-negative Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with HER2-negative inoperable or recurrent breast cancer. Exclusion criteria: Patients with high-grade bone marrow depression (absolute neutrophil count less than 1,000 /mm^3, absolute platelet count less than 75,000 /mm^3). Patients with a history of hypersensitivity to the ingredients of HALAVEN. Women who are pregnant or may be pregnant. Patients with a history of use of HALAVEN.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HALAVEN treatment group of primary or secondary chemotherapy<br>Patients with HER2-negative recurrent breast cancer who have received 0 or 1 chemotherapy regimen for recurrent breast cancer. | |
| HALAVEN treatment group of tertiary or later chemotherapy<br>Patients with HER2-negative inoperable or recurrent breast cancer who have received 2 or more chemotherapy regimens for inoperable or recurrent breast cancer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events and serious adverse events |  | Baseline and up to 2 years after the initial dose of HALAVEN | 
| Number of participants with peripheral neuropathy | 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. | 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 | 
| Time to resolution of peripheral neuropathy |  | Baseline and up to 2 years after the initial dose of HALAVEN | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER2-Negative Inoperable or Recurrent Breast Cancer, Japan, Eribulin Mesylate