An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer

27/09/2012
15/12/2016
EU PAS number:
EUPAS3014
Study
Planned
Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Population studied

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)

Estimated number of subjects

1500
Study design details

Main study objective

This is a prospective OCS designed to follow patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts will be included:•Patients with HER2-normal disease receiving their first cytotoxic chemotherapy and/or targeted therapy (1500 patients)•Patients with HR-positive tumors receiving their first HT for advanced disease (500 patients) Patients wh

Data analysis plan

TBD