An observational post-marketing surveillance study on the status and factors for the development of peripheral neuropathy in patients with HER2-negative inoperable or recurrent breast cancer in Japan (HAL02T)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Non-randomised clinical trial

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ERIBULIN MESYLATE
• Medical condition to be studied:
  Breast cancer recurrent

Population studied

• Short description of the study population:
  Patients with HER-2 negative inoperable or recurrent breast cancer treated with eribulin.
• 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:
  Breast Cancer patients
• Estimated number of subjects:
  590

Study design details

• Main study objective:
  To clarify the factors affecting the incidence of peripheral neuropathy
• Data analysis plan:
  The analysis method is descriptive and includes assessment of patient history and concomitant medications and assessment of the incidence, latency, resolution and treatment of peripheral neuropathy