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

Browse trials for

• Breast Neoplasms 12,520

Keywords

• Breast neoplasms
• Metastatic breast cancer
• E7389

Study population

Groups and cohorts

• 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

Interventions

• DrugEribulin mesylate

  intravenous infusion

  Also known as: Halaven, E7389

Primary outcomes

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

   Time frame: 6 months

Secondary outcomes

1. Progression-Free Survival (PFS)

   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.

   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)

2. Overall Survival (OS)

   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.

   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)

3. Time to treatment failure (TTF)

   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.

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

4. Tumor response rate (TRR)

   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.

   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)

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

   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.

   Time frame: 6 months

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

   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.

   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)

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

   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.

   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)

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

   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.

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

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

   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.

   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)

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

    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.

    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)

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

    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.

    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)

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

    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.

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

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

    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.

    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)

14. Number of participants with the indicated action to TEAEs

    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.

    Time frame: 6 months

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

    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.

    Time frame: 6 months

16. Number of participants using supportive drugs to treat AEs

    Treatment of adverse events will be collected retrospectively.

    Time frame: 6 months

17. Median number of eribulin cycles

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

    Time frame: 6 months

18. Number of participants experiencing a dose reduction

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

    Time frame: 6 months

19. Mean duration of treatment

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

    Time frame: 6 months

20. Mean duration of response

    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.

    Time frame: 6 months

21. Mean dose intensity

    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.

    Time frame: 6 months

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

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

    Time frame: 6 months