Clinical trial NCT03437083: A Study to Investigate the Efficacy and Safety of Eribulin in Korean Breast Cancer Participants
Official title: A Nationwide, Multi-institutional Retrospective Study of Efficacy and Safety of Eribulin in Korean Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced or Metastatic Breast Cancer
Keywords: Breast neoplasms
Metastatic breast cancer
E7389
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 340
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female participants diagnosed with locally advanced or metastatic breast cancer, who had experience with eribuin-treatment

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.


Eligibility 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:

* Not applicable

Primary outcomes:
measure: Progression-free survival (PFS) rate at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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)
measure: Overall Survival (OS)
timeFrame: 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)
measure: Time to treatment failure (TTF)
timeFrame: From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years)
measure: Tumor response rate (TRR)
timeFrame: 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)
measure: Number of participants with any treatment-emergent adverse event (TEAE)
timeFrame: 6 months
measure: PFS in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)
timeFrame: 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)
measure: OS in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)
timeFrame: 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)
measure: TTF in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)
timeFrame: From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years)
measure: TRR in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)
timeFrame: 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)
measure: PFS rate in eribulin-treated breast cancer participants comparing early (≤ third line) to late (≥ fourth line) use
timeFrame: 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)
measure: OS in eribulin-treated breast cancer participants comparing early (≤ third line) to late (≥ fourth line) use
timeFrame: 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)
measure: TTF in eribulin-treated breast cancer participants comparing early (≤ third line) to late (≥ fourth line) use
timeFrame: From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years)
measure: TRR in eribulin-treated breast cancer participants comparing early (≤third line) to late (≥ fourth line) use
timeFrame: 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)
measure: Number of participants with the indicated action to TEAEs
timeFrame: 6 months
measure: Number of participants with TEAEs resulting in discontinuation of eribulin
timeFrame: 6 months
measure: Number of participants using supportive drugs to treat AEs
timeFrame: 6 months
measure: Median number of eribulin cycles
timeFrame: 6 months
measure: Number of participants experiencing a dose reduction
timeFrame: 6 months
measure: Mean duration of treatment
timeFrame: 6 months
measure: Mean duration of response
timeFrame: 6 months
measure: Mean dose intensity
timeFrame: 6 months
measure: Number of participants with the indicated reason for treatment discontinuation
timeFrame: 6 months
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Eisai Trial site_03
city: Busan
country: Korea, Republic of
facility: Eisai Trial site_04
city: Busan
country: Korea, Republic of
facility: Eisai Trial site_05
city: Busan
country: Korea, Republic of
facility: Eisai Trial site_06
city: Daegu
country: Korea, Republic of
facility: Eisai Trial site_09
city: Daejeon
country: Korea, Republic of
facility: Eisai Trial site_13
city: Gwangju
country: Korea, Republic of
facility: Eisai Trial site_14
city: Seoul
country: Korea, Republic of
facility: Eisai Trial site_01
city: Seoul
country: Korea, Republic of
facility: Eisai Trial site_02
city: Seoul
country: Korea, Republic of
facility: Eisai Trial site_07
city: Seoul
country: Korea, Republic of
facility: Eisai Trial site_10
city: Seoul
country: Korea, Republic of
facility: Eisai Trial site_11
city: Seoul
country: Korea, Republic of
facility: Eisai Trial site_12
city: Suwon
country: Korea, Republic of
facility: Eisai Trial site_08
Study officials:
References: