Breast Cancer

HER2 REAL (D9673R00005)

A Multicountry, Multicentre, Noninterventional Retrospective Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer.

Trial overview

Topic

Breast Cancer

Eligibility criteria

  • Adult female or male patients =18 years old or ‘adults’ according to age of majority as defined by the local
  • regulations
  • Patient or next of kin/legal representative willing and able to provide written informed consent according to the
  • local regulations unless a waiver is granted by the local IRB/IEC/EC
  • Patients’ medical records showing diagnosis of HER2-positive unresectable or mBC (can be either de novo
  • advanced disease, progression or recurrence of previous early-stage HER2-positive BC) since the available date of TDM1
  • (Kadcyla) through reimbursement or patient access programme as a valid local treatment option or 01 January
  • 2017, whichever is earlier, and with availability of at least 12 months of follow-up data (from the date of diagnosis of
  • unresectable or mBC) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis
  • Patients completing at least 2 LOTs for HER2-positive unresectable or mBC

Study details

This multicountry, multicenter, retrospective, non-interventional study involving patients diagnosed with HER2- positive unresectable or metastatic breast cancer mBC will be conducted to understand the demographic and clinico-pathological profile of the patients, diagnostic practices for human epidermal growth factor receptor 2 (HER2) status, current treatment landscape and sequencing of therapies, associated burden of toxicities with all lines of treatment (LOTs), and survival outcomes in the real-world setting.

Further information

Please click here for more information.

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