Metastatic Breast CancerEUFORIA-1NCT02790320
Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer
An observational study of Metastatic Breast Cancer, run by Eisai Farmacêutica S.A. at 17 sites in Spain.
Trial summary
The purpose of this study was to evaluate the efficacy and safety of eribulin in standard clinical practice in patients with locally recurrent or metastatic advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- Type of treatment
- Injection or infusion
- How many people
- 112 participants
- Where
- 17 sitesSpain
- Study dates
- Jun 2012to Nov 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally recurrent or metastatic advanced breast cancer who were treated with eribulin
Who may be able to join
- Patients diagnosed with locally recurrent or metastatic advanced breast cancer, previously treated with taxanes and anthracyclines, unless these were not indicated.
- Clinical and/or radiological documentation of location and extension of the disease at the time of starting treatment with eribulin. Patients with measurable diseases and those patients who only have non-measurable lesions are eligible.
- Medical history documentation including analytical control data (blood count and serum chemistry including hepatic and renal functions) carried out at least one week before starting treatment with eribulin. (Determining the CA15-3 tumor marker is not indispensable).
- Eribulin monotherapy (at least 1 dose) between April 2011 and March 2012, both inclusive.
- Availability of a medical history allowing monitoring of clinical progression of the patients during and after treatment with eribulin.
Who cannot join
- Diagnosis of any type of cancer in the last 5 years, except for non-melanoma skin cancer, cervical intraepithelial neoplasia or contralateral breast cancer.
- Patients having received any other anti-tumor treatment, whether conventional or experimental, during the week prior to starting treatment with eribulin. Treatment with bisphosphonate and corticoids is allowed if they are clinically indicated and started 28 days before treatment with eribulin.
- Lack of clinical status documentation after completing treatment with eribulin or, at least, after having been administered 3 initial cycles. This can arise in any of the following cases (they are not excluding):
- Patients whose Medical History does not state the reason and date for interruption of treatment with eribulin and their subsequent clinical progression.
- Patients still undergoing treatment with eribulin on March 31, 2012, for whom there is no data for at least the first 3 cycles.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
Hospital Comarcal de Barbastro
Huesca
Complejo Hospitalario de Jaen
Jaén
Hospital Arnau de Vilanova
Lleida
Clínica Román
Madrid
Hospital 12 de Octubre
Madrid
Hospital Clínico San Carlos
Madrid
Hospital Madrid Norte Sanchinarro
Madrid
Hospital MD Anderson
Madrid
Hospital Quirón Madrid
Madrid
Hospital Sanitas La Moraleja
Madrid
Hospital Universitario Morales Meseguer
Murcia
Hospital de Navarra
Navarra
Hospital Clínico Universitario de Salamanca
Salamanca
Clínica Esperanza de Triana
Seville
Hospital Universitario Virgen del Rocío
Seville
Hospital Virgen Macarena
Seville
Hospital Miguel Servet
Zaragoza
About this study
Official title: Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer: Observational Retrospective Analysis
The purpose of this study was to evaluate the efficacy and safety of eribulin in standard clinical practice in patients with locally recurrent or metastatic advanced breast cancer.
Read the detailed description
This was an observational, cross-sectional, retrospective, multicenter study conducted in Spain. During the year after authorization of the drug by the European Medicines Agency (EMA), patients in the compassionate use program (public sites) and patients treated in private sites (no purchase restrictions) who received at least 1 dose of treatment with eribulin per approved label at any of the 17 Spanish sites with the highest numbers of treated cases during that period (minimum 3 patients/site) were enrolled in this observational study. Approximately 112 patients will be enrolled in the study.
- Conditions
- Metastatic Breast Cancer
- Keywords
- Eribulin mesylate, Halaven, 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 |
|---|---|---|
| Patients with locally recurrent or metastatic breast cancer | Patients received 1.4 mg/m2 eribulin, administered intravenously on day 1 and 8 of each 21 day cycle until disease progression or unmanageable toxicity, per routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate
Measured: From signing of informed consent up to 1 year
Secondary outcomes (10)
Objective response rate
Measured: From signing of informed consent up to 1 year
Overall survival
Measured: From signing of informed consent up to 1 year
Progression-free survival
Measured: From signing of informed consent up to 1 year
Change from baseline in tumor markers CA15-3
Measured: Baseline and up to 1 year
Time to response from start of treatment
Measured: From signing of informed consent up to 1 year
Duration of response
Measured: From signing of informed consent up to 1 year
Duration of stabilization
Measured: From signing of informed consent up to 1 year
Post-treatment survival
Measured: From signing of informed consent up to 1 year
Progression time after interruption
Measured: From signing of informed consent up to 1 year
Number of patients with adverse events / serious adverse events
Measured: From signing of informed consent up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startJun 2012
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Time perspective
- Retrospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Farmacêutica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790320
- Sponsor's protocol ID
- OBU-SW-H-01
- Acronym
- EUFORIA-1
- Status last verified
- Apr 2016
- First submitted
- 31 May 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer: Observational Retrospective Analysis
- ClinicalTrials.gov ID
- NCT02790320
- Acronym / sponsor ID
- EUFORIA-1 / OBU-SW-H-01
- Conditions
- Metastatic Breast Cancer
- Keywords
- Eribulin mesylate, Halaven, Breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Eisai Farmacêutica S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 3 Jun 2016 (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.
The purpose of this study was to evaluate the efficacy and safety of eribulin in standard clinical practice in patients with locally recurrent or metastatic advanced breast cancer.
Detailed description
This was an observational, cross-sectional, retrospective, multicenter study conducted in Spain. During the year after authorization of the drug by the European Medicines Agency (EMA), patients in the compassionate use program (public sites) and patients treated in private sites (no purchase restrictions) who received at least 1 dose of treatment with eribulin per approved label at any of the 17 Spanish sites with the highest numbers of treated cases during that period (minimum 3 patients/site) were enrolled in this observational study. Approximately 112 patients will be enrolled in the study.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with locally recurrent or metastatic breast cancer | – | –Patients received 1.4 mg/m2 eribulin, administered intravenously on day 1 and 8 of each 21 day cycle until disease progression or unmanageable toxicity, per routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally recurrent or metastatic advanced breast cancer who were treated with eribulin
Key inclusion criteria (5 listed)
- Patients diagnosed with locally recurrent or metastatic advanced breast cancer, previously treated with taxanes and anthracyclines, unless these were not indicated.
- Clinical and/or radiological documentation of location and extension of the disease at the time of starting treatment with eribulin. Patients with measurable diseases and those patients who only have non-measurable lesions are eligible.
- Medical history documentation including analytical control data (blood count and serum chemistry including hepatic and renal functions) carried out at least one week before starting treatment with eribulin. (Determining the CA15-3 tumor marker is not indispensable).
- Eribulin monotherapy (at least 1 dose) between April 2011 and March 2012, both inclusive.
- Availability of a medical history allowing monitoring of clinical progression of the patients during and after treatment with eribulin.
Key exclusion criteria (5 listed)
- Diagnosis of any type of cancer in the last 5 years, except for non-melanoma skin cancer, cervical intraepithelial neoplasia or contralateral breast cancer.
- Patients having received any other anti-tumor treatment, whether conventional or experimental, during the week prior to starting treatment with eribulin. Treatment with bisphosphonate and corticoids is allowed if they are clinically indicated and started 28 days before treatment with eribulin.
- Lack of clinical status documentation after completing treatment with eribulin or, at least, after having been administered 3 initial cycles. This can arise in any of the following cases (they are not excluding):
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
Clinical benefit rate
Time frame: From signing of informed consent up to 1 year
10 secondary outcomes
Objective response rate
Time frame: From signing of informed consent up to 1 year
Overall survival
Time frame: From signing of informed consent up to 1 year
Progression-free survival
Time frame: From signing of informed consent up to 1 year
Change from baseline in tumor markers CA15-3
Time frame: Baseline and up to 1 year
Time to response from start of treatment
Time frame: From signing of informed consent up to 1 year
Duration of response
Time frame: From signing of informed consent up to 1 year
Duration of stabilization
Time frame: From signing of informed consent up to 1 year
Post-treatment survival
Time frame: From signing of informed consent up to 1 year
Progression time after interruption
Time frame: From signing of informed consent up to 1 year
Number of patients with adverse events / serious adverse events
Time frame: From signing of informed consent up to 1 year
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 3 Jun 2016.
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Eisai Farmacêutica S.A. at 17 sites in Spain.
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 5 inclusion and 5 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 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain. 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?
Clinical benefit rate (time frame: From signing of informed consent 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 3 Jun 2016.