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The objective of this observatory is to evaluate the effecacy of Eribulin in patients with metastatic breast cancer on a recent prescription period.
Part of the data collection will be retrospective and the other part will be prospective for patients started treatment by Eribulin between November 2014 and September 2015. It will allow a better assessment on the safety profile of this drug.
Approximately one third of patients treated for localized breast cancer will present a metastatic evolution and 5% of patients are metastatic immediately.
At this stage, the malignancy is incurable with a median survival from 2 to 3 years.
Metastatic breast cancer treatment is part of a multidisciplinary approach. These two objectives are to prolong survival and improve quality of life. At present, there is no standard after the first line of chemotherapy, with fe strategy studies Eribulin is now a new therapeutic option to consider. Many patients have benefited from this treatment option and it seems interesting to evaluate in real life the effecacy and tolerance of chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reproline | this is an observational trial ; there is no intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin (ReProLine) | Other | this is an observational trial ; there is no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is defined as the time between the first administration of Eribulin and death from any cause. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival by subgroup | Overall survival is defined as the time between the first administration of Eribulin and death from any cause in the following subgroups:
|
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Inclusion Criteria:
Exclusion Criteria:
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The population includes all patients treated by Eribulin for breast cancer whose treatment has been starting between January 2014 and September 2015
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| Name | Affiliation | Role |
|---|---|---|
| Anne PATSOURIS, MD | Institut de Cancerologie de l'Ouest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de l'Ouest | Angers | 49933 | France | |||
| CHU Jean Minjoz |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C490954 | eribulin |
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| 1 year |
| Progression free survival | Progression-free survival is defined as the time between the first administration of Eribulin and the first demonstrated progression by image | 1 year |
| Treatment response rate | Treatment response rate will be assessed by:
| 1 year |
| Treatment's tolerance | The treatment's tolerance will be assessed by collecting adverse events ≥ grade 3 quoted according to NCI CTCAE v4.0 classification. | 1 year |
| Besançon |
| 25030 |
| France |
| CHU | Brest | 29200 | France |
| Centre Jean Bernard | Le Mans | 72000 | France |
| Centre Léon Berard | Lyon | 69373 | France |
| Institut de Cancerologie de l'Ouest | Nantes | 44802 | France |
| Centre Jean Godinot | Reims | 51100 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Clinique Armoricaine de Radiologie | Saint-Brieuc | 22000 | France |
| CH | St-Malo | 35400 | France |
| Centre Paul Strauss | Strasbourg | 67065 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54500 | France |
| D017437 |
| Skin and Connective Tissue Diseases |