Retroprospective Real Life Observatory of Eribulin
- Conditions
- Metastatic Breast Cancer
- Interventions
- Other: Eribulin (ReProLine)
- Registration Number
- NCT02393287
- Lead Sponsor
- Institut Cancerologie de l'Ouest
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 753
- Age ≥ 18 years
- Patient with breast cancer, histologically proven, metastatic or locally advanced
- Patient treated by Eribulin between January and October 2014 (for the retrospective part) or between November 2014 and September 2015 (for the prospective part).
- Patient with at least an assessment of the response to Eribulin
- Presence of other neoplasia
- Man
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Reproline Eribulin (ReProLine) this is an observational trial ; there is no intervention
- Primary Outcome Measures
Name Time Method Overall Survival 1 year Overall survival is defined as the time between the first administration of Eribulin and death from any cause.
- Secondary Outcome Measures
Name Time Method Overall Survival by subgroup 1 year Overall survival is defined as the time between the first administration of Eribulin and death from any cause in the following subgroups:
* According to the administration line of Eribulin: administration in third line or more versus administration in first or second line or for locally advanced cancer,
* in HER2 + population
* in triple negative population
* in the elderly (\> 70 years)
* in the overweight population (BMI\> 30)Progression free survival 1 year Progression-free survival is defined as the time between the first administration of Eribulin and the first demonstrated progression by image
Treatment response rate 1 year Treatment response rate will be assessed by:
* the best response obtained between the first administration of treatment with Eribulin and demonstrated progression by image (according to RECIST 1.1 criteria) or clinical
* the clinical benefit (number of complete responses, partial responses or persistent stabilities mare than 6 months).Treatment's tolerance 1 year The treatment's tolerance will be assessed by collecting adverse events ≥ grade 3 quoted according to NCI CTCAE v4.0 classification.
Trial Locations
- Locations (12)
Institut de Cancerologie de l'Ouest
🇫🇷Nantes, France
CHU Jean Minjoz
🇫🇷Besancon, France
CHU
🇫🇷Brest, France
Centre Jean Bernard
🇫🇷Le Mans, France
Centre Léon Berard
🇫🇷Lyon, France
Centre Jean Godinot
🇫🇷Reims, France
Centre Eugène Marquis
🇫🇷Rennes, France
Centre Henri Becquerel
🇫🇷Rouen, France
CH
🇫🇷Saint Malo, France
Clinique Armoricaine de Radiologie
🇫🇷Saint Brieuc, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre Les Nancy, France