Breast CancerNCT02441764
Halaven Post-Marketing Surveillance (PMS)
An observational study of Breast Cancer, run by Eisai Korea Inc. at 12 sites in South Korea.
Trial summary
This is a PMS to observe the safety profile of Halaven in normal clinical practice setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- How many people
- 3,000 participants
- Where
- 12 sitesSouth Korea
- Study dates
- Mar 2013to Aug 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: Participants who are prescribed with Halaven per approved prescribing information of Halaven will be enrolled in the study.
Who may be able to join
- Participants who meet all of the following criteria will be eligible for inclusion in the study:
- Participants with following indication: Participants with locally advanced or metastatic breast cancer who have previously received at least two chemotherapeutic regimens which should have included an anthracycline and a taxane.
- Participants who have verbal or written consent for use of personal and medical information.
- Investigators will refer to indications regarding inclusion criteria.
Who cannot join
- Hypersensitivity to the active substance or to any of the excipients
- Breast feeding
- Pregnancy
- Investigators will refer to indications and contraindications regarding exclusion criteria.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Study site
Busan
Study site
Chuncheongnam-do
Study site
Chungcheongbuk-do
Study site
Chungcheongnam-do
Study site
Daegu
Study site
Gwangju
Study site
Gyeonggi-do
Study site
Gyeongsanbuk-do
Study site
Gyeongsannam-do
Study site
Jeollabuk-do
Study site
Jeollanam-do
Study site
Seoul
About this study
Official title: Post-Marketing Surveillance of Halaven Injection in Korean Patients
This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.
- Conditions
- Breast Cancer
- Keywords
- Halaven, Eribulin Mesylate, locally advanced or metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Halaven | Participants who are prescribed with Halaven per approved prescribing information of Halaven. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
Measured: Up to 1 year
Secondary outcomes (1)
Tumor response to Halaven treatment
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMar 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 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
- NCT02441764
- Sponsor's protocol ID
- EKI-PMS-1201
- Status last verified
- Jun 2018
- First submitted
- 8 May 2015
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Halaven Injection in Korean Patients
- ClinicalTrials.gov ID
- NCT02441764
- Acronym / sponsor ID
- EKI-PMS-1201
- Conditions
- Breast Cancer
- Keywords
- Halaven, Eribulin Mesylate, locally advanced or metastatic breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 12 May 2015 (estimated)
- 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.
This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Halaven | – | –Participants who are prescribed with Halaven per approved prescribing information of Halaven. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who are prescribed with Halaven per approved prescribing information of Halaven will be enrolled in the study.
Key inclusion criteria (4 listed)
- Participants who meet all of the following criteria will be eligible for inclusion in the study:
- Participants with following indication: Participants with locally advanced or metastatic breast cancer who have previously received at least two chemotherapeutic regimens which should have included an anthracycline and a taxane.
- Participants who have verbal or written consent for use of personal and medical information.
- Investigators will refer to indications regarding inclusion criteria.
Key exclusion criteria (4 listed)
- Hypersensitivity to the active substance or to any of the excipients
- Breast feeding
- Pregnancy
- Investigators will refer to indications and contraindications regarding exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
Time frame: Up to 1 year
1 secondary outcome
Tumor response to Halaven treatment
Time frame: Up to 12 weeks
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 10 Mar 2020.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Eisai Korea Inc. at 12 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 4 inclusion and 4 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 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions (time frame: Up to 1 year). 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 10 Mar 2020.