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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin | Drug | Eribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity based on the CTCAE v4.03 criteria | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Claire HARDY-BESSARD, MD | Clinique Armoricaine de Radiologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | France | ||||
| Centre Hospitalier d'Auxerre |
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| Auxerre |
| 89000 |
| France |
| Institut Ste Catherine | Avignon | France |
| Clinique Tivoli | Bordeaux | France |
| Hôpital Fleyriat | Bourg-en-Bresse | 01012 | France |
| Hôpital Morvan - Centre Hospitalier Universitaire | Brest | 29200 | France |
| centre Francois baclesse | Caen | France |
| Hôpital Privé Sainte-Marie | Chalon-sur-Saône | 71100 | France |
| Centre Hospitalier William Morey | Chalon-sur-Saône | France |
| Centre d'Oncologie et de Radiothérapie | Dijon | 21000 | France |
| Centre Hospitalier la Dracénie | Draguignan | 83300 | France |
| Centre Hospitalier Intercommunal | Fréjus | France |
| Hôpital Privé Drôme Ardèche - Clinique Pasteur | Guilherand-Granges | 07500 | France |
| Clinique de la Sauvegarde | Lyon | 69337 | France |
| Centre Léon Bérard | Lyon | 69373 | France |
| Hôpital Privé Clairval | Marseille | France |
| Hôpital de Mont-de-Marsan | Mont-de-Marsan | 40024 | France |
| Centre d'oncologie de Gentilly | Nancy | France |
| Centre Catherine de Sienne | Nantes | France |
| Centre Antoine Lacassagne | Nice | France |
| Centre Hospitalier Régional | Orléans | France |
| Institut Curie - Hopital Claudius Régaud | Paris | 75005 | France |
| Hôpital Cochin | Paris | 75014 | France |
| Groupe Hospitalier Saint-Joseph | Paris | 75674 | France |
| Centre Catalan d'Oncologie | Perpignan | 66000 | France |
| Centre Hospitalier Lyon-sud | Pierre-Bénite | 69495 | France |
| Centre Hospitalier de la Région d'Annecy | Pringy | 74374 | France |
| Clinique Courlancy | Reims | 51100 | France |
| Institut Jean Godinot | Reims | France |
| Centre Henri Becquerel | Rouen | France |
| Anne-Claire Hardy-Bessard, MD | Saint-Brieuc | 22015 | France |
| Clinique Armoricaine de Radiologie | Saint-Brieuc | France |
| Centre Hospitalier Privé de Saint-Grégoire | Saint-Grégoire | 35760 | France |
| GHPSO - Site Senlis | Senlis | 60309 | France |
| Centre de Radiothérapie - Clinique Sainte-Anne | Strasbourg | 67000 | France |
| Centre Hospitalier de Thonon-les-Bains | Thonon-les-Bains | 74203 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| CHU Bretonneau | Tours | France |
| Centre Hospitalier de Valence | Valence | 26953 | France |
| Centre Hospitalier Bretagne Atlantique | Vannes | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C490954 | eribulin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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