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NCT Number: NCT02393287

Retroprospective Real Life Observatory of Eribulin

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut de Cancerologie de l'Ouest, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Presence of other neoplasia
  • Man

Treatment and study plan

Eribulin (ReProLine)

Other

this is an observational trial ; there is no intervention

Primary outcomes

  1. Overall Survival

    Time frame: 1 year

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

Secondary outcomes

  1. Overall Survival by subgroup

    Time frame: 1 year

    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)

  2. Progression free survival

    Time frame: 1 year

    Progression-free survival is defined as the time between the first administration of Eribulin and the first demonstrated progression by image

  3. Treatment response rate

    Time frame: 1 year

    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).

  4. Treatment's tolerance

    Time frame: 1 year

    The treatment's tolerance will be assessed by collecting adverse events ≥ grade 3 quoted according to NCI CTCAE v4.0 classification.

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

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

Acronym: ReProLine

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 19, 2015
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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