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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

651 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-03

Study Completion Date

2018-01-21

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.

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Detailed Description

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Conditions

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Breast Cancer HER2-negative Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HALAVEN treatment group of primary or secondary chemotherapy

Patients with HER2-negative recurrent breast cancer who have received 0 or 1 chemotherapy regimen for recurrent breast cancer.

No interventions assigned to this group

HALAVEN treatment group of tertiary or later chemotherapy

Patients with HER2-negative inoperable or recurrent breast cancer who have received 2 or more chemotherapy regimens for inoperable or recurrent breast cancer.

No interventions assigned to this group

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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No