Locally Advanced or Metastatic Breast CancerNCT03437083
A Study to Investigate the Efficacy and Safety of Eribulin in Korean Breast Cancer Participants
An observational study of Locally Advanced or Metastatic Breast Cancer, run by Eisai Korea Inc. at 14 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Locally Advanced or Metastatic Breast Cancer
- What is being tested?
- Eribulin mesylate
- Type of treatment
- Injection or infusion
- How many people
- 340 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 25 Jan 2018to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female participants diagnosed with locally advanced or metastatic breast cancer, who had experience with eribuin-treatment
Who may be able to join
- Confirmed diagnosis of locally advanced or metastatic breast cancer
- Participants who were treated with Eribulin between 01 June, 2014 and 31 December, 2016
Who cannot join
- Not applicable
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Eisai Trial site_03
Ansan
Eisai Trial site_04
Busan
Eisai Trial site_05
Busan
Eisai Trial site_06
Busan
Eisai Trial site_09
Daegu
Eisai Trial site_13
Daejeon
Eisai Trial site_14
Gwangju
Eisai Trial site_01
Seoul
Eisai Trial site_02
Seoul
Eisai Trial site_07
Seoul
Eisai Trial site_10
Seoul
Eisai Trial site_11
Seoul
Eisai Trial site_12
Seoul
Eisai Trial site_08
Suwon
About this study
Official title: A Nationwide, Multi-institutional Retrospective Study of Efficacy and Safety of Eribulin in Korean Breast Cancer Patients
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.
- Being tested
- Eribulin mesylate
- Keywords
- Breast neoplasms, Metastatic breast cancer, E7389
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin mesylateDrug
Also called Halaven, E7389
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Eribulin mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (22)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Number of participants using supportive drugs to treat AEs
Treatment of adverse events will be collected retrospectively.
Measured: 6 months
Median number of eribulin cycles
Data will be collected to observe a treatment pattern of eribulin in the real world.
Measured: 6 months
Number of participants experiencing a dose reduction
Data will be collected to observe a treatment pattern of eribulin in the real world.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start25 Jan 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437083
- Sponsor's protocol ID
- E7389-M082-602
- Status last verified
- Jun 2018
- First submitted
- 8 Jan 2018
- Last updated
- 25 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nationwide, Multi-institutional Retrospective Study of Efficacy and Safety of Eribulin in Korean Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03437083
- Acronym / sponsor ID
- E7389-M082-602
- Keywords
- Breast neoplasms, Metastatic breast cancer, E7389
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin | – | Drug: Eribulin mesylateEribulin 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female participants diagnosed with locally advanced or metastatic breast cancer, who had experience with eribuin-treatment
Key inclusion criteria (2 listed)
- Confirmed diagnosis of locally advanced or metastatic breast cancer
- Participants who were treated with Eribulin between 01 June, 2014 and 31 December, 2016
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eribulin mesylateAlso: Halaven, E7389intravenous infusion | Drug | Eribulin |
Primary outcome
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.
22 secondary outcomes
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)
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)
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)
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)
Number of participants with any treatment-emergent adverse event (TEAE)
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)
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)
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)
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)
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
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
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
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
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
Time frame: 6 months
Number of participants with TEAEs resulting in discontinuation of eribulin
Time frame: 6 months
Number of participants using supportive drugs to treat AEs
Time frame: 6 months
Median number of eribulin cycles
Time frame: 6 months
Number of participants experiencing a dose reduction
Time frame: 6 months
Mean duration of treatment
Time frame: 6 months
Mean duration of response
Time frame: 6 months
Mean dose intensity
Time frame: 6 months
Number of participants with the indicated reason for treatment discontinuation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced or Metastatic Breast Cancer, run by Eisai Korea Inc. at 14 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) rate at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.