Metastatic Breast CancerPhase 2ESMERALDANCT01941407
First Line Metastatic Breast Cancer Treatment (ESMERALDA)
A Phase 2 study testing Eribulin in people with Metastatic Breast Cancer, run by ARCAGY/ GINECO GROUP at 40 sites in France.
Trial summary
The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra toxicities. It could be interesting to explore the combination of bev + eribulin in first line metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- 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
- 61 participants
- Where
- 40 sitesFrance
- Study dates
- Nov 2013to Mar 2016
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 ans
- Patient with metastatic mammary adenocarcinoma
- Hormone receptors ER and PR positive or negative for HER 2 negative
Who cannot join
- Prior chemotherapy for metastatic disease
- Previous treatment with eribulin or bevacizumab
- Presence of symptomatic brain metastases or meningeal
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
France40 sites
Centre Paul Papin
Angers
Centre Hospitalier d'Auxerre
Auxerre, 89000
Institut Ste Catherine
Avignon
Clinique Tivoli
Bordeaux
Hôpital Fleyriat
Bourg-en-Bresse, 01012
Hôpital Morvan - Centre Hospitalier Universitaire
Brest, 29200
centre Francois baclesse
Caen
Hôpital Privé Sainte-Marie
Chalon-sur-Saône, 71100
Centre Hospitalier William Morey
Chalon-sur-Saône
Centre d'Oncologie et de Radiothérapie
Dijon, 21000
Centre Hospitalier la Dracénie
Draguignan, 83300
Centre Hospitalier Intercommunal
Fréjus
Hôpital Privé Drôme Ardèche - Clinique Pasteur
Guilherand-Granges, 07500
Clinique de la Sauvegarde
Lyon, 69337
Centre Léon Bérard
Lyon, 69373
Hôpital Privé Clairval
Marseille
Hôpital de Mont-de-Marsan
Mont-de-Marsan, 40024
Centre d'oncologie de Gentilly
Nancy
Centre Catherine de Sienne
Nantes
Centre Antoine Lacassagne
Nice
Centre Hospitalier Régional
Orléans
Institut Curie - Hopital Claudius Régaud
Paris, 75005
Hôpital Cochin
Paris, 75014
Groupe Hospitalier Saint-Joseph
Paris, 75674
Centre Catalan d'Oncologie
Perpignan, 66000
Centre Hospitalier Lyon-sud
Pierre-Bénite, 69495
Centre Hospitalier de la Région d'Annecy
Pringy, 74374
Clinique Courlancy
Reims, 51100
Institut Jean Godinot
Reims
Centre Henri Becquerel
Rouen
Anne-Claire Hardy-Bessard, MD
Saint-Brieuc, 22015
Clinique Armoricaine de Radiologie
Saint-Brieuc
Centre Hospitalier Privé de Saint-Grégoire
Saint-Grégoire, 35760
GHPSO - Site Senlis
Senlis, 60309
Centre de Radiothérapie - Clinique Sainte-Anne
Strasbourg, 67000
Centre Hospitalier de Thonon-les-Bains
Thonon-les-Bains, 74203
Clinique Pasteur
Toulouse, 31076
CHU Bretonneau
Tours
Centre Hospitalier de Valence
Valence, 26953
Centre Hospitalier Bretagne Atlantique
Vannes
About this study
Official title: A PHASE II TRIAL EVALUATING THE COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER
The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra toxicities.
It could be interesting to explore the combination of bev + eribulin in first line metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Eribulin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EribulinDrug
Also called Drug: Bevacizumab
Eribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV
| Study group | Role | What they receive |
|---|---|---|
| Association eribulin and bevacizumab | Experimental | Drug: eribulin 1,23mg/m²; d1 and d8 in IV, all 3 weeks until 6 cycles or progression Drug: bevacizumab 15m/kg ; d1 in IV, all 3 weeks until 6 cycles or progression or toxicity Receives: Drug: Eribulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with non progressive disease
The principal endpoint is to determine the disease control rate (or rate of non-progression) at one year in patients with metastatic breast cancer treated in the first line setting by a combination of eribulin/bevacizumab.
In this open-label trial, the sample size is calculated based on Simon's two-stage design, used to test whether the disease control rate at one year will be at least 50%, a clinically promising rate, versus a rate of 33%, a rate that is not clinically promising.
Considering a type I risk (alpha) error of 5%, with 54 patients, this study has an 80% power to detect a disease control rate at one year of 50%.
Measured: 12 months
Secondary outcomes (1)
Toxicity based on the CTCAE v4.03 criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2014
- Study completionMar 2016
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Claire HARDY-BESSARD, MD, Principal investigator, Clinique Armoricaine de Radiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941407
- Sponsor's protocol ID
- GINECO-BR110
- Acronym
- ESMERALDA
- Status last verified
- Mar 2016
- First submitted
- 10 Sep 2013
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE II TRIAL EVALUATING THE COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER
- ClinicalTrials.gov ID
- NCT01941407
- Acronym / sponsor ID
- ESMERALDA / GINECO-BR110
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Sep 2013 (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 efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra toxicities.
It could be interesting to explore the combination of bev + eribulin in first line metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Association eribulin and bevacizumab | Experimental | Drug: EribulinDrug: eribulin 1,23mg/m²; d1 and d8 in IV, all 3 weeks until 6 cycles or progression Drug: bevacizumab 15m/kg ; d1 in IV, all 3 weeks until 6 cycles or progression or toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 ans
- Patient with metastatic mammary adenocarcinoma
- Hormone receptors ER and PR positive or negative for HER 2 negative
Key exclusion criteria (3 listed)
- Prior chemotherapy for metastatic disease
- Previous treatment with eribulin or bevacizumab
- Presence of symptomatic brain metastases or meningeal
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 |
|---|---|---|
| EribulinAlso: Drug: BevacizumabEribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV | Drug | Association eribulin and bevacizumab |
Primary outcome
Number of patient with non progressive disease
Time frame: 12 months
The principal endpoint is to determine the disease control rate (or rate of non-progression) at one year in patients with metastatic breast cancer treated in the first line setting by a combination of eribulin/bevacizumab. In this open-label trial, the sample size is calculated based on Simon's two-stage design, used to test whether the disease control rate at one year will be at least 50%, a clinically promising rate, versus a rate of 33%, a rate that is not clinically promising. Considering a type I risk (alpha) error of 5%, with 54 patients, this study has an 80% power to detect a disease control rate at one year of 50%.
1 secondary outcome
Toxicity based on the CTCAE v4.03 criteria
Time frame: 12 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 17 Mar 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.
Anne-Claire HARDY-BESSARD, MD principal investigator
Clinique Armoricaine de Radiologie
40 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 Metastatic Breast Cancer, run by ARCAGY/ GINECO GROUP at 40 sites in France.
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 3 inclusion and 3 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in France. 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?
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?
Number of patient with non progressive disease (time frame: 12 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 17 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.