Loreline Study: Characterization of Long Responders Under Eribuline
Condition: Breast Cancer Patients; Therapy Related Tumor
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      There is currently no strict recommendations for the management of patients who have received
      at least one or two lines of anthracyclines-based chemotherapy and taxane therapy for
      advanced breast cancer. However, Halaven® can represent a therapeutic alternative at this
      stage of the disease.

      Indeed, since march 2011, Halaven® has been granted Marketing Authorization (MA) for patients
      with metastatic or locally advanced breast cancer, whose disease has progressed after at
      least two lines of chemotherapy for advanced disease (3rd line). In these patients, the
      indication for marketing authorization specifies that the previous treatment must have
      included an anthracycline and a taxane except in patients who can not receive these
      treatments.

      An extension of indication was obtained on 27/06/2014 with a marketing authorization obtained
      in the treatment of locally advanced or second-line metastatic breast cancer.

      According to the Transparency Commission of the High Authority of Health (HAS dated September
      23, 2015), Halaven® (Eribulin), administered as monotherapy, in the third line of treatment
      and beyond, represents a therapeutic option, because it brings an improvement of medical
      service rendered compared to Capecitabine (XELODA®) and Vinorelbine (NAVELBINE®).

      In addition, Halaven® (Eribuline) administrated as monotherapy in second-line of treatment is
      an alternative to other monotherapies recommended for the treatment of locally advanced or
      metastatic relapsed breast cancer, such as Capecitabine (XELODA®). and Vinorelbine
      (NAVELBINE®). But, no improvement of medical service rendered has been reported in second
      line of treatment.

      According to these results, it would be interesting to have additional data concerning the
      use of Halaven® (Eribulin), in the second and third lines, but also in the fourth line.

      For this purpose, the investigators propose to perform a study in patients with metastatic
      breast cancer who have failed treatment after the first line and beyond.

      In this study, the investigators will be particularly interested in "long-responder"
      patients, that is to say, in objective response or with stability for 6 months or more under
      Halaven®, in order to better characterize these patients. Patients must have been treated by
      Halaven between September 2011 and December 2016, to have a sufficient follow-up for the
      survival data of the patients.
    

Detailed description: 
      The investigators will perform a cross-sectional study in patients with metastatic breast
      cancer who have failed treatment after the first line and beyond.

      In this study, the investigators will be particularly interested in "long-responder"
      patients, that is to say, in objective response or with stability for 6 months or more under
      Halaven®, in order to better characterize these patients. Patients must have been treated by
      Halaven between September 2011 (the year of obtaining the MA in the 3rd line of treatment)
      and December 2016, to have a sufficient follow-up for the survival data of the patients.

      The investigators will also focus on patients with liver metastases because there is limited
      data in this population.
    

Intervention name(s): Patients in long response during Halaven® treatment
Intervention type(s): Other
Intervention description(s): Data collection
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is a nationale, multicentric, retrospective study in which will be inclused metastatic
        breast cancer patients treated by Halaven® in second, third line or fourth line.

        Only "long responder" patients treated by Halaven®, since Septembre 2011 to December 2016,
        will be included in this study.

        A patient will be considered as " long responder " if she is in objective response or
        stability for 6 months or more from the start of Halaven® treatment