Tucatinib in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer Who Received at Least Two Prior Anti-HER2 Treatment Regimens: a Multicenter, International, Prospective, Non-interventional Study in Germany and Austria (TRACE)
The objective of this non-interventional study (NIS) is to evaluate tucatinib (TUKYSA®) combined with trastuzumab and capecitabine in adult patients with locally advanced or metastatic HER2-positive breast cancer who have been previously treated with at least two anti-HER2 treatment regimens in a real-world setting,
• Aged 18 years or older.
• Histologically confirmed HER2+ breast cancer with HER2 positivity defined as a 3+ score by immunohistochemistry (IHC) or a positive result by in situ hybridization (ISH), optionally combined with a IHC2+ score.
• Diagnosis of locally advanced or metastatic HER2+ breast cancer, including patients with brain metastases.
• Prior treatment with at least two prior anti-HER2-based regimens.
• Decision for treatment with tucatinib in combination with trastuzumab and capecitabine according to current SmPC of tucatinib either in
• 1st/2nd palliative treatment line (Cohort 1) or 3rd/4th palliative treatment line (Cohort 2).
• Progression after or intolerance of last systemic anti-HER2-based therapy.
• Indication for treatment with tucatinib as assessed by the treating physician.
• Signed written informed consent (only if patient is alive at time of inclusion, not applicable for retrospective inclusion of deceased patients).
• Knowledge of German language.
• Other criteria according to current SmPC of tucatinib