Retroprospective Real Life Observatory of Eribulin
ReProLine
Activity and Toxicity Profile of Eribulin Mesylate in Pretreated Metastatic Breast Cancer: an Observational Multicentric Retroprospective Study
1 other identifier
observational
753
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 4, 2015
CompletedFirst Posted
Study publicly available on registry
March 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedMay 9, 2019
May 1, 2019
1.8 years
February 4, 2015
May 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival is defined as the time between the first administration of Eribulin and death from any cause.
1 year
Secondary Outcomes (4)
Overall Survival by subgroup
1 year
Progression free survival
1 year
Treatment response rate
1 year
Treatment's tolerance
1 year
Study Arms (1)
Reproline
this is an observational trial ; there is no intervention
Interventions
Eligibility Criteria
The population includes all patients treated by Eribulin for breast cancer whose treatment has been starting between January 2014 and September 2015
You may qualify if:
- 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
You may not qualify if:
- Presence of other neoplasia
- Man
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Institut de Cancerologie de l'Ouest
Angers, 49933, France
CHU Jean Minjoz
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne PATSOURIS, MD
Institut de Cancerologie de l'Ouest
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2015
First Posted
March 19, 2015
Study Start
November 1, 2014
Primary Completion
September 1, 2016
Study Completion
January 1, 2017
Last Updated
May 9, 2019
Record last verified: 2019-05