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Completed

NCT Number: NCT02371174

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms HER2-negative Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Osaka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of participants with adverse events and serious adverse events

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

  2. Number of participants with peripheral neuropathy

    Time frame: 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.

  3. Number of participants with adverse drug reactions

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

  4. Time to onset of peripheral neuropathy

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

  5. Time to resolution of peripheral neuropathy

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

Secondary outcomes

  1. Overall survival

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 25, 2015
Registry last updated
Jul 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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