Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 159 for:    eribulin
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03437083
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )

Brief Summary:
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.

Condition or disease Intervention/treatment
Locally Advanced or Metastatic Breast Cancer Drug: Eribulin mesylate

Layout table for study information
Study Type : Observational
Actual Enrollment : 340 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Nationwide, Multi-institutional Retrospective Study of Efficacy and Safety of Eribulin in Korean Breast Cancer Patients
Actual Study Start Date : January 25, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Eribulin
Eribulin was administered at a dose of 1.4 milligrams per meters squared (mg/m^2) (as eribulin 1.23 mg/m^2) by a 2- to 5-minute intravenous infusion or as a diluted solution on Day 1 and Day 8 every 21 days.
Drug: Eribulin mesylate
intravenous infusion
Other Names:
  • Halaven
  • E7389




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and female participants diagnosed with locally advanced or metastatic breast cancer, who had experience with eribuin-treatment
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437083


Locations
Layout table for location information
Korea, Republic of
Eisai Trial site_03
Ansan, Korea, Republic of
Eisai Trial site_04
Busan, Korea, Republic of
Eisai Trial site_05
Busan, Korea, Republic of
Eisai Trial site_06
Busan, Korea, Republic of
Eisai Trial site_09
Daegu, Korea, Republic of
Eisai Trial site_13
Daejeon, Korea, Republic of
Eisai Trial site_14
Gwangju, Korea, Republic of
Eisai Trial site_01
Seoul, Korea, Republic of
Eisai Trial site_02
Seoul, Korea, Republic of
Eisai Trial site_07
Seoul, Korea, Republic of
Eisai Trial site_10
Seoul, Korea, Republic of
Eisai Trial site_11
Seoul, Korea, Republic of
Eisai Trial site_12
Seoul, Korea, Republic of
Eisai Trial site_08
Suwon, Korea, Republic of
Sponsors and Collaborators
Eisai Korea Inc.

Layout table for additonal information
Responsible Party: Eisai Korea Inc.
ClinicalTrials.gov Identifier: NCT03437083     History of Changes
Other Study ID Numbers: E7389-M082-602
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Eisai Inc. ( Eisai Korea Inc. ):
Breast neoplasms
Metastatic breast cancer
E7389

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases