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

Eisai Co., Ltd.651 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

651

Conditions

Breast Cancer HER2-negative Breast Cancer

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

Osaka, Japan

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Number of participants with adverse events and serious adverse events

Time frame: 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.

Time frame: Baseline, and every two months after the initial dose of HALAVEN up to 2 years

Number of participants with adverse drug reactions

Time frame: Baseline and up to 2 years after the initial dose of HALAVEN

Time to onset of peripheral neuropathy

Time frame: Baseline and up to 2 years after the initial dose of HALAVEN

Time to resolution of peripheral neuropathy

Time frame: Baseline and up to 2 years after the initial dose of HALAVEN

Secondary Outcomes

Overall survival

Time frame: Up to 2 years

Data from ClinicalTrials.gov

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