Breast NeoplasmPhase 2MERIBELNCT02061085
Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment
A Phase 2 study testing Eribulin in people with Breast Neoplasm and Metastasis, run by MedSIR at 11 sites in Spain.
Trial summary
Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy and tolerability of first line single agent Eribulin in patients with HER2-negative metastatic breast carcinoma (MBC) previously exposed to taxanes for early stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm, Metastasis
- What is being tested?
- Eribulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 11 sitesSpain
- Study dates
- Jul 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Histologically confirmed metastatic breast cancer HER2 negative, stage IIIb/IV
- Previous history of early disease (stage I-IIIb), surgically resected and treated with standard chemotherapy for at least 12 weeks at which included a taxane or ixabepilone
- Patients must have progressed in the 36 months after treatment with taxanes or ixabepilone.
- Age ≥ 18 years
- Given written informed consent
- Index of Eastern Cooperative Oncology Group (ECOG) of 0 or 1
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- Patients must have recovered from toxicities related with previous treatment (CTC ≥ 1)
- Measurable or evaluable disease (RECIST 1.1)
- Adequate bone marrow function
- Adequate hepatic function
- Adequate renal function
- Life expectancy ≥ 3 months
Who cannot join
- Breast cancer patients initially diagnosed with local disease advanced or metastatic disease.
- Patients who have previously received cytotoxic therapy Hormone therapy permitted if the patients have interrupted it at least two weeks before the start of the study treatment.
- Major surgery or significant traumatic injury during the 4 weeks prior to study treatment or patients who may require major surgery during the assay.
- Brain metastases or leptomeningeal uncontrolled.
- Serious medical condition and / or not properly controlled (unstable angina, lung function severe impaired, uncontrolled diabetes, active serious infection,liver disease, HIV seropositivity, active bleeding diathesis)
- Other malignancies in the last three years, except: cervical carcinoma in situ, basal cell carcinoma or squamous cell skin carcinoma,that have been properly treated
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- Patients who are pregnant or breastfeeding, or adults with reproductive capacity wich are not using effective contraception.
- Patients receiving chronic treatment with systemic corticosteroids or other immunosuppressive drugs (except corticosteroids with a daily dose equivalent to prednisone ≤ 20mg on a stable dose regimen one minimum of 4 weeks prior to study entry. Topical and inhaled corticosteroids are allowed
- Active alcoholism or drugs addiction documented.
- Prior history of noncompliance with medical regimens
- Patients who do not want or can not comply with the study protocol
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Study site
A Coruña, Galicia
Study site
Badajoz, Extremadura
Study site
Barcelona, Catalonia
Study site
Las Palmas de Gran Canaria, Canary Islands
Study site
Madrid
Study site
Oviedo, Principality of Asturias
Study site
Palma de Mallorca, Balearic Islands
Study site
Pamplona, Navarre
Study site
Salamanca, Castille and León
Study site
Valencia
Study site
Zaragoza, Aragon
About this study
Official title: A Phase IIa Prospective, Multicenter, Open and Not Controlled of the Efficacy and Tolerability on the First Line Treatment With Eribulin as a Unic Agent on Patients With HER2 Negative Metastatic Breast Cancer Previously Treated With Taxanes
Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy and tolerability of first line single agent Eribulin in patients with HER2-negative metastatic breast carcinoma (MBC) previously exposed to taxanes for early stage.
The primary objective of the study is to determine the median time to progression achieved with Eribulin. Other secondary objectives will be; overall response rate, clinical benefit rate, time to treatment progression, duration of response and toxicity profile.
- Conditions
- Breast Neoplasm, Metastasis
- Being tested
- Eribulin
- Keywords
- Breast Neoplasm Metastasis, Receptor,HER-2, Eribulin, Furans, ketones, Antimitotic agent
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EribulinDrug
| Study group | Role | What they receive |
|---|---|---|
| monotherapy treatment with Eribulin | Experimental | Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days Receives: Drug: Eribulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
Measured: Through study completion, up to 27 months
Secondary outcomes (3)
Duration of Response
Duration of response
Measured: Through study completion, up to 27 months
Clinical Benefit Rate
Measured: Through study completion, up to 27 months
Progression Free Survival
Measured: Through study completion, up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast NeoplasmStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Llombart, MD, Principal investigator, Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061085
- Sponsor's protocol ID
- OBU-SW-H-02
- Other IDs
- 2012-004463-41
- Acronym
- MERIBEL
- Status last verified
- Jun 2025
- First submitted
- 10 Jan 2014
- Last updated
- 8 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Prospective, Multicenter, Open and Not Controlled of the Efficacy and Tolerability on the First Line Treatment With Eribulin as a Unic Agent on Patients With HER2 Negative Metastatic Breast Cancer Previously Treated With Taxanes
- ClinicalTrials.gov ID
- NCT02061085
- Acronym / sponsor ID
- MERIBEL / OBU-SW-H-02
- Conditions
- Breast Neoplasm, Metastasis
- Keywords
- Breast Neoplasm Metastasis, Receptor,HER-2, Eribulin, Furans, ketones, Antimitotic agent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Posted 8 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy and tolerability of first line single agent Eribulin in patients with HER2-negative metastatic breast carcinoma (MBC) previously exposed to taxanes for early stage.
The primary objective of the study is to determine the median time to progression achieved with Eribulin. Other secondary objectives will be; overall response rate, clinical benefit rate, time to treatment progression, duration of response and toxicity profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| monotherapy treatment with Eribulin | Experimental | Drug: EribulinEribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed metastatic breast cancer HER2 negative, stage IIIb/IV
- Previous history of early disease (stage I-IIIb), surgically resected and treated with standard chemotherapy for at least 12 weeks at which included a taxane or ixabepilone
- Patients must have progressed in the 36 months after treatment with taxanes or ixabepilone.
- Age ≥ 18 years
- Given written informed consent
Key exclusion criteria (11 listed)
- Breast cancer patients initially diagnosed with local disease advanced or metastatic disease.
- Patients who have previously received cytotoxic therapy Hormone therapy permitted if the patients have interrupted it at least two weeks before the start of the study treatment.
- Major surgery or significant traumatic injury during the 4 weeks prior to study treatment or patients who may require major surgery during the assay.
- Brain metastases or leptomeningeal uncontrolled.
- Serious medical condition and / or not properly controlled (unstable angina, lung function severe impaired, uncontrolled diabetes, active serious infection,liver disease, HIV seropositivity, active bleeding diathesis)
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 | Drug | monotherapy treatment with Eribulin |
Primary outcome
Time to Progression
Time frame: Through study completion, up to 27 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
3 secondary outcomes
Duration of Response
Time frame: Through study completion, up to 27 months
Clinical Benefit Rate
Time frame: Through study completion, up to 27 months
Progression Free Survival
Time frame: Through study completion, up to 27 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Antonio Llombart, MD principal investigator
Valencia
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eribulin in people with Breast Neoplasm and Metastasis, run by MedSIR at 11 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 12 inclusion and 11 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 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Progression (time frame: Through study completion, up to 27 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 8 Jun 2025.