Clinical trial NCT02393287: Retroprospective Real Life Observatory of Eribulin
Official title: Activity and Toxicity Profile of Eribulin Mesylate in Pretreated Metastatic Breast Cancer: an Observational Multicentric Retroprospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 753
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival by subgroup
timeFrame: 1 year
measure: Progression free survival
timeFrame: 1 year
measure: Treatment response rate
timeFrame: 1 year
measure: Treatment's tolerance
timeFrame: 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de l'Ouest
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Brest
country: France
facility: CHU
city: Le Mans
country: France
facility: Centre Jean Bernard
city: Lyon
country: France
facility: Centre Léon Berard
city: Nantes
country: France
facility: Institut de Cancerologie de l'Ouest
city: Reims
country: France
facility: Centre Jean Godinot
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Brieuc
country: France
facility: Clinique Armoricaine de Radiologie
city: Saint Malo
country: France
facility: CH
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Institut de Cancerologie de l'Ouest
name: Anne PATSOURIS, MD
role: PRINCIPAL_INVESTIGATOR
References: