Retroprospective Real Life Observatory of Eribulin (ReProLine)

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Other: Eribulin (ReProLine)

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.

• Study Type: Observational
• Enrollment (Actual): 753

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Institut de Cancérologie de l'Ouest
  • Besancon, France, 25030
    • CHU Jean Minjoz
  • Brest, France, 29200
    • CHU
  • Le Mans, France, 72000
    • Centre Jean Bernard
  • Lyon, France, 69373
    • Centre Leon Berard
  • Nantes, France, 44802
    • Institut de Cancérologie de l'Ouest
  • Reims, France, 51100
    • Centre Jean Godinot
  • Rennes, France, 35042
    • Centre Eugène Marquis
  • Rouen, France, 76038
    • Centre Henri Becquerel
  • Saint Brieuc, France, 22000
    • Clinique Armoricaine de Radiologie
  • Saint Malo, France, 35400
    • CH
  • Strasbourg, France, 67065
    • Centre Paul Strauss
  • Vandoeuvre Les Nancy, France, 54500
    • Centre Alexis Vautrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The population includes all patients treated by Eribulin for breast cancer whose treatment has been starting between January 2014 and September 2015

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Reproline; this is an observational trial ; there is no intervention	Other: Eribulin (ReProLine); this is an observational trial ; there is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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: 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
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: 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
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

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: Anne PATSOURIS, MD, Institut de Cancérologie de l'Ouest

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 7, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ICO-A-RSD-2014-07