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.

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 Overview

• Status: Completed
• Conditions: Breast Cancer; HER2-negative Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 651

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

HER2-negative subjects who are treated with HALAVEN for the first time.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

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	Time Frame
Overall survival	Up to 2 years

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2014
• Primary Completion (Actual): January 21, 2018
• Study Completion (Actual): January 21, 2018

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Japan; Eribulin Mesylate; HER2-Negative Inoperable or Recurrent Breast Cancer
• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neuromuscular Diseases; Breast Neoplasms; Peripheral Nervous System Diseases
• Other Study ID Numbers: HAL02T