CompletedNCT02061085MERIBELUpdated Jun 8, 2025Results posted

Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment

A Phase 2 interventional study of Eribulin in Breast Neoplasm and Metastasis, sponsored by MedSIR. Completed at 11 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.

Sponsored by MedSIR · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 53
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

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 studied

Breast Neoplasm
Metastasis

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Keywords

Breast Neoplasm Metastasis
Receptor,HER-2
Eribulin
Furans, ketones
Antimitotic agent

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 53 is close to the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

MedSIR is the lead sponsor of 55 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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
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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 53 participants (actual)

Study arms

Experimental
monotherapy treatment with Eribulin
Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days
Drug: Eribulin

Interventions

DrugEribulin

What researchers measure

Primary outcomes

Time to Progression
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
Time frame: Through study completion, up to 27 months

Secondary outcomes

Duration of Response
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

Posted Jun 8, 2025

Participant flow

A total of 53 taxane-resistant patients with HER2- locally advanced or MBC treated with Eribulin as first-line chemotherapy were enrolled between 2013 and 2015 in a total of 14 sites.

Participant flow — Overall Study
Milestone	Monotherapy Treatment With Eribulin
Started	53
Completed	45
Not completed	8
Withdrew: Adverse event	8

Outcome measures

PrimaryTime to Progression

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)

Time frame:: Through study completion, up to 27 months
Reported as:: Median · months

Time to Progression
months	Monotherapy Treatment With Eribulin
Time to Progression	4.1 (3.2 to 6.6)

SecondaryDuration of Response

Duration of response

Time frame:: Through study completion, up to 27 months
Reported as:: Median · months

Duration of Response
months	Monotherapy Treatment With Eribulin
Duration of Response	4.5 (2.1 to 20.9)

SecondaryClinical Benefit Rate

Time frame:: Through study completion, up to 27 months
Reported as:: Count of participants · Participants

Clinical Benefit Rate
Participants	Monotherapy Treatment With Eribulin
Clinical Benefit Rate	14

SecondaryProgression Free Survival

Time frame:: Through study completion, up to 27 months
Reported as:: Median · Months

Progression Free Survival
Months	Monotherapy Treatment With Eribulin
Progression Free Survival	4.1 (3.2 to 6.6)

Adverse events

Collected over Through study completion, up to 27 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Monotherapy Treatment With Eribulin	22/53 (41.5%)	11/53 (20.8%)	39/53 (73.6%)

Most frequent serious events

Showing 10 of 15

Most frequent serious events
Event	Monotherapy Treatment With Eribulin
VomitingGastrointestinal disorders	2/53
Pleural effusionVascular disorders	1/53
Pulmonar embolismVascular disorders	1/53
Cerebrovascular accidentVascular disorders	1/53
Pulmonary tromboembolismVascular disorders	1/53
CephaleaGeneral disorders	1/53
AnxietyGeneral disorders	1/53
Parcial hepatoctomyGastrointestinal disorders	1/53
NauseaGastrointestinal disorders	1/53
Mucositis managementRespiratory, thoracic and mediastinal disorders	1/53

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	Monotherapy Treatment With Eribulin
AlopeciaSkin and subcutaneous tissue disorders	18/53
NauseaGastrointestinal disorders	14/53
Neuropathy peripheralNervous system disorders	10/53
ConstipationGastrointestinal disorders	10/53
Anorexia and bulimia syndromeGastrointestinal disorders	10/53
Abdominal painGastrointestinal disorders	7/53
AstheniaMusculoskeletal and connective tissue disorders	7/53
Musculoskeletal disorderMusculoskeletal and connective tissue disorders	7/53
Bone painMusculoskeletal and connective tissue disorders	5/53
MyalgiaMusculoskeletal and connective tissue disorders	5/53

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Monotherapy Treatment With Eribulin
<=18 years	0
Between 18 and 65 years	37
>=65 years	16

Age, Continuous
Age, Continuous(years)	Monotherapy Treatment With Eribulin
Median	47 (23 to 83)

Sex: Female, Male
Sex: Female, Male(Participants)	Monotherapy Treatment With Eribulin
Female	53
Male	0

Region of Enrollment
Region of Enrollment(participants)	Monotherapy Treatment With Eribulin
Spain	49
Portugal	4

Study locations

11 sites

Zaragoza, Aragón, Spain
Oviedo, Asturias, Spain
Salamanca, Castilla Y León, Spain
Barcelona, Cataluña, Spain
Badajoz, Extremadura, Spain
La Coruña, Galicia, Spain
Palma de Mallorca, Illes Balears, Spain
Las Palmas De Gran Canaria, Islas Canarias, Spain
Pamplona, Navarra, Spain
Madrid, Spain
Valencia, Spain

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02061085
Lead sponsor: MedSIR
Responsible party: Sponsor
First posted: Feb 12, 2014
Start date: Jul 2013
Primary completion: Dec 2015
Completion: Dec 2015
Results posted: Jun 8, 2025
Last update: Jun 8, 2025

Study contacts

Antonio Llombart, MD

principal investigator · Valencia

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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