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

Breast Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371174
• Other study ID #: HAL02T
• Status: Completed
• Start date: September 3, 2014
• Est. completion date: January 21, 2018

Study information

• Verified date: July 2018
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 651
• Est. completion date: January 21, 2018
• Est. primary completion date: January 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-negative Breast Cancer
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events and serious adverse events		Baseline and up to 2 years after the initial dose of HALAVEN
Primary	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
Primary	Number of participants with adverse drug reactions		Baseline and up to 2 years after the initial dose of HALAVEN
Primary	Time to onset of peripheral neuropathy		Baseline and up to 2 years after the initial dose of HALAVEN
Primary	Time to resolution of peripheral neuropathy		Baseline and up to 2 years after the initial dose of HALAVEN
Secondary	Overall survival		Up to 2 years