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.
Study Type
OBSERVATIONAL
Enrollment
340
intravenous infusion
Eisai Trial site_03
Ansan, South Korea
Eisai Trial site_04
Busan, South Korea
Eisai Trial site_05
Busan, South Korea
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
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)
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)
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)
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)
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Eisai Trial site_06
Busan, South Korea
Eisai Trial site_09
Daegu, South Korea
Eisai Trial site_13
Daejeon, South Korea
Eisai Trial site_14
Gwangju, South Korea
Eisai Trial site_01
Seoul, South Korea
Eisai Trial site_02
Seoul, South Korea
Eisai Trial site_07
Seoul, South Korea
...and 4 more locations
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
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)
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)
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)
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)
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)
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)
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)
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)
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
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
Number of participants using supportive drugs to treat AEs
Treatment of adverse events will be collected retrospectively.
Time frame: 6 months
Median number of eribulin cycles
Data will be collected to observe a treatment pattern of eribulin in the real world.
Time frame: 6 months
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
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
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
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
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