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Completed

NCT Number: NCT03437083

A Study to Investigate the Efficacy and Safety of Eribulin in Korean Breast Cancer Participants

The primary objective of the study is to observe efficacy in terms of progression-free survival rate at 6 months in eribulin-treated breast cancer participants retrospectively.

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Key information

Conditions

Locally Advanced or Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisai Trial site_03, Ansan, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of locally advanced or metastatic breast cancer
  • Participants who were treated with Eribulin between 01 June, 2014 and 31 December, 2016

Exclusion criteria

  • Not applicable

Treatment and study plan

eribulin mesylate

Drug

intravenous infusion

Other names: Halaven, E7389

Primary outcomes

  1. Progression-free survival (PFS) rate at 6 months

    Time frame: 6 months

    PFS rate at 6 months is estimated based on the tumor response evaluation and is defined as the proportion of participants alive and progression-free at 6 months from the initial treatment of eribulin.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: From the start date of therapy with eribulin to the date of disease progression or death from any cause (1 day to up to approximately 2 years)

    PFS is defined as the time from the start date of therapy with eribulin to the date of disease progression or death from any cause. Participants without progression will be censored, progression free at the date of late follow-up.

  2. Overall Survival (OS)

    Time frame: From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years)

    OS is defined as the time from the start date of therapy with eribulin to the date of death from any cause or last follow-up.

  3. Time to treatment failure (TTF)

    Time frame: From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years)

    TTF is defined as a time from first treatment with eribulin to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.

  4. Tumor response rate (TRR)

    Time frame: From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years)

    TRR will be evaluated by medical records. ORR is defined as the sum of obtained PR and CR and the clinical benefit rate (CBR) is defined as the sum of PR, CR and stable disease (SD) maintained for at least six months. Disease control rate (DCR) is defined as the sum of PR, CR and SD.

  5. Number of participants with any treatment-emergent adverse event (TEAE)

    Time frame: 6 months

    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

  6. PFS in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)

    Time frame: From the start date of therapy with eribulin to the date of disease progression or death from any cause (1 day to up to approximately 2 years)

    PFS is defined as the time from the start date of therapy with eribulin to the date of disease progression or death from any cause. Participants without progression will be censored, progression free at the date of late follow-up.

  7. OS in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)

    Time frame: From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years)

    OS is defined as the time from the start date of therapy with eribulin to the date of death from any cause or last follow-up.

  8. TTF in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)

    Time frame: From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years)

    TTF is defined as a time from first treatment with eribulin to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.

  9. TRR in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)

    Time frame: From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years)

    TRR will be evaluated by medical records. ORR is defined as the sum of obtained PR and CR and the CBR is defined as the sum of PR, CR and SD maintained for at least six months. DCR is defined as the sum of PR, CR and SD.

  10. PFS rate in eribulin-treated breast cancer participants comparing early (≤ third line) to late (≥ fourth line) use

    Time frame: From the start date of therapy with eribulin to the date of disease progression or death from any cause (1 day to up to approximately 2 years)

    PFS is defined as the time from the start date of therapy with eribulin to the date of disease progression or death from any cause. Participants without progression will be censored, progression free at the date of late follow-up.

  11. OS in eribulin-treated breast cancer participants comparing early (≤ third line) to late (≥ fourth line) use

    Time frame: From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years)

    OS is defined as the time from the start date of therapy with eribulin to the date of death from any cause or last follow-up.

  12. TTF in eribulin-treated breast cancer participants comparing early (≤ third line) to late (≥ fourth line) use

    Time frame: From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years)

    TTF is defined as a time from first treatment with eribulin to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.

  13. TRR in eribulin-treated breast cancer participants comparing early (≤third line) to late (≥ fourth line) use

    Time frame: From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years)

    TRR will be evaluated by medical records. ORR is defined as the sum of obtained (PR) and CR and the CBR is defined as the sum of PR, CR and SD maintained for at least 6 months. DCR is defined as the sum of PR, CR and SD.

  14. Number of participants with the indicated action to TEAEs

    Time frame: 6 months

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

  15. Number of participants with TEAEs resulting in discontinuation of eribulin

    Time frame: 6 months

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

  16. Number of participants using supportive drugs to treat AEs

    Time frame: 6 months

    Treatment of adverse events will be collected retrospectively.

  17. Median number of eribulin cycles

    Time frame: 6 months

    Data will be collected to observe a treatment pattern of eribulin in the real world.

  18. Number of participants experiencing a dose reduction

    Time frame: 6 months

    Data will be collected to observe a treatment pattern of eribulin in the real world.

  19. Mean duration of treatment

    Time frame: 6 months

    Duration of treatment is defined as the time from documentation of the start of eribulin treatment to the date of permanent discontinuation.

  20. Mean duration of response

    Time frame: 6 months

    Duration of response is defined as the time from the first documented evidence of CR or PR (whichever status is recorded first) until the first documented sign of disease progression or death due to any cause.

  21. Mean dose intensity

    Time frame: 6 months

    Dose intensity is defined as the amount of drug milligrams per meters squared (mg/m^2) delivered to a participant in a week of treatment.

  22. Number of participants with the indicated reason for treatment discontinuation

    Time frame: 6 months

    Data will be collected to observe a treatment pattern of eribulin in the real world.

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Official study title

A Nationwide, Multi-institutional Retrospective Study of Efficacy and Safety of Eribulin in Korean Breast Cancer Patients

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
Jan 25, 2019

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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