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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02371174

Enrollment

651

Registered

2015-02-25

Start date

2014-09-03

Completion date

2018-01-21

Last updated

2018-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, HER2-negative Breast Cancer

Keywords

HER2-Negative Inoperable or Recurrent Breast Cancer, Japan, Eribulin Mesylate

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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	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	—
Time to resolution of peripheral neuropathy	Baseline and up to 2 years after the initial dose of HALAVEN	—

Secondary

Measure	Time frame
Overall survival	Up to 2 years

Countries

Japan

Outcome results