Retroprospective Real Life Observatory of Eribulin

Institut Cancerologie de l'Ouest753 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

753

Conditions

Metastatic Breast Cancer

Interventions

Eribulin (ReProLine)OTHER

this is an observational trial ; there is no intervention

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Institut de Cancerologie de l'Ouest

Angers, France

CHU Jean Minjoz

Besançon, France

CHU

Brest, France

Outcomes

Primary Outcomes

Overall Survival

Overall survival is defined as the time between the first administration of Eribulin and death from any cause.

Time frame: 1 year

Secondary Outcomes

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)

Time frame: 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

Time frame: 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).

Time frame: 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.

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.