Retroprospective Real Life Observatory of Eribulin

Metastatic Breast Cancer Clinical Trial

— ReProLine  

Official title:

Activity and Toxicity Profile of Eribulin Mesylate in Pretreated Metastatic Breast Cancer: an Observational Multicentric Retroprospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393287
• Other study ID #: ICO-A-RSD-2014-07
• Status: Completed
• Start date: November 2014
• Est. completion date: January 2017

Study information

• Verified date: May 2019
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 753
• Est. completion date: January 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Patient with breast cancer, histologically proven, metastatic or locally advanced

3. Patient treated by Eribulin between January and October 2014 (for the retrospective part) or between November 2014 and September 2015 (for the prospective part).

4. Patient with at least an assessment of the response to Eribulin

Exclusion Criteria:

1. Presence of other neoplasia

2. Man

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Other:
• Eribulin (ReProLine)
this is an observational trial ; there is no intervention

Locations

Country	Name	City	State
France	Institut de Cancerologie de l'Ouest	Angers
France	CHU Jean Minjoz	Besancon
France	CHU	Brest
France	Centre Jean Bernard	Le Mans
France	Centre Léon Berard	Lyon
France	Institut de Cancerologie de l'Ouest	Nantes
France	Centre Jean Godinot	Reims
France	Centre Eugène Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Clinique Armoricaine de Radiologie	Saint Brieuc
France	CH	Saint Malo
France	Centre Paul Strauss	Strasbourg
France	Centre Alexis Vautrin	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival is defined as the time between the first administration of Eribulin and death from any cause.	1 year
Secondary	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: 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)	1 year
Secondary	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
Secondary	Treatment response rate	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).	1 year
Secondary	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