Incidence and Resolution of Eribulin-induced peripheral Neuropathy (IRENE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, post authorization, single-arm, prospective, multicenter study

Study drug and medical condition

• Name of medicine:
  HALAVEN
• Medical condition to be studied:
  Breast cancer metastatic

Population studied

• Short description of the study population:
  Female patients aged ≥18 years with locally advanced or metastatic breast cancer (MBC) treated with erubulin in a real life setting in Germany.; Inclusion criteria:; 1. Locally advanced or MBC eligible for treatment with eribulin according to Fachinformation; 2. Maximum of two prior chemotherapeutic regimens for advanced disease.; 3. Age ≥18 years at the time of informed consent.; 4. Ability to understand and willingness to respond to questions related to their health.; 5. Decision for the patient to start treatment with eribulin has been made prior to inclusion in this study.; 6. Signed written informed consent.; ; Exclusion criteria:; 1. Previous treatment with eribulin in any line of treatment.; 2. Contraindication according to Fachinformation of eribulin.; 3. Pregnancy or lactation.; 4. Participation in an interventional clinical trial at the same time.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Metastatic breast cancer patients
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  To characterize and determine the incidence of eribulin-induced PN, and frequency and time to resolution of eribulin-induced PN in patients treated with eribulin in a real life setting for locally advanced or MBC following one or two prior chemotherapeutic regimens for advanced disease.
• Data analysis plan:
  Epidemiological methods will be employed for data analyses. Descriptive analyses will be performed of all collected data. For quantative variables, descriptive statistics will include the number of patients (n), the number of patients will missing values (Nmiss), mean, standard deviation, median, 25%, 75% and 90% and 95% quantiles, minimum and maximum.