CompletedNot Applicable

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

Japan651 participantsStarted 2014-09-03

Plain-language 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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with adverse events and serious adverse events

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

Number of participants with peripheral neuropathy

Timeframe: Baseline, and every two months after the initial dose of HALAVEN up to 2 years

Number of participants with adverse drug reactions

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

Time to onset of peripheral neuropathy

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

Time to resolution of peripheral neuropathy

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

Trial details

NCT IDNCT02371174

SponsorEisai Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-01-21

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with adverse events and serious adverse events

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

Number of participants with peripheral neuropathy

Timeframe: Baseline, and every two months after the initial dose of HALAVEN up to 2 years

Number of participants with adverse drug reactions

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

Time to onset of peripheral neuropathy

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

Time to resolution of peripheral neuropathy

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