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.
- Adult female or male patients =18 years old or ‘adults’ according to age of majority as defined by the local
- 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
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.