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OpenTrials
Completed

NCT Number: NCT02443428

Eribulin Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry

The purpose of this prospective observational registry is to monitor safety of eribulin in routine clinical practice. Additionally, this study will also assess the effectiveness of eribulin in real-life settings.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The participants have to meet all of the following criteria to be eligible to enter into the prospective registry:

  • Participants older than 18 years of age
  • Willing and able to provide informed consent
  • Diagnosis of locally advanced or metastatic breast cancer
  • Progression after up to two previous chemotherapy regimens for advanced disease. Prior therapy should have included an anthracycline and a taxanes in either the adjuvant or advanced setting unless not suitable
  • Adequate bone marrow, liver, and renal function
  • Life expectancy greater than 12 weeks

Exclusion criteria

Participants meeting the following criteria will not be permitted to enter the study:

  • Prior treatment with eribulin
  • Participants who have received more than two prior chemotherapeutic regimens for advanced disease

Treatment and study plan

Primary outcomes

  1. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: From date of first administration of study drug up to 30 days after last administration of study drug or until approximately 2 years

    Safety assessment will consist of monitoring of all AEs, including SAEs at every visit. All participants will be evaluable for safety from the time of their first treatment with eribulin.

Secondary outcomes

  1. Tumour response

    Time frame: From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years

  2. Overall survival (OS)

    Time frame: From date of first administration of study drug to date of death or up to approximately 2 years

  3. Demographic and clinical characteristics

    Time frame: Up to approximately 2 years

  4. Duration of treatment

    Time frame: Historical data collected at Baseline

  5. Incidence of dose delays

    Time frame: From date of first administration up to approximately 2 years

  6. Incidence of dose reductions

    Time frame: From date of first administration up to approximately 2 years

  7. Relative dose intensity (RDI) of eribulin

    Time frame: From date of first administration up to approximately 2 years

  8. Treatment patterns for locally advanced or metastatic breast cancer

    Time frame: Historical data collected at Baseline

Sponsors and collaborators

Lead sponsor

Eisai Limited

Industry

Registry information

Official study title

Eribulin (HALAVEN) Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 13, 2015
Registry last updated
Apr 15, 2016

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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