HER2-PET as a Diagnostic Tool in Breast Cancer Patients With a Clinical Dilemma
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Concordance between HER2-PET results and anti-HER2 therapy
Concordance between HER2-PET results and anti-HER2 therapy is defined as HER2 positive lesion(s) on HER2-PET and subsequent anti-HER2 therapy; or no HER2 positive lesions on HER2-PET and no subsequent anti-HER2 therapy. It is considered a clinically relevant contribution of HER2-PET to anti-HER2-therapy decisions if there is a concordance in at least 2/3 of included patients.
about 2 years (end of study)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)