Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor lesions in breast cancer patients is essential for diagnostic and therapeutic management of metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional information, have so far not been able to replace the biopsy. To solve this problem, non-invasive whole body visualization and quantification of HER2 expression by means of the HER2-PET may be a valuable tool. In this prospective multicenter imaging study, eligible patients will receive one HER2-PET and CTC analysis in addition to standard work up for metastatic disease. Subsequent administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three questionnaires, one before HER2-PET and two after HER2-PET.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
University Medical Center
Groningen, Netherlands
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.
Time frame: about 2 years (end of study)
Correlation of HER2-PET results and questionnaire results regarding clinical value of HER2-PET for the referring clinician
Correlation of HER2-PET result (assessed about 1 week after scan) and questionnaire results (before, directly after, and 3 months after scan)
Time frame: about 2 years (end of study)
Correlation of HER2-PET results with standard conventional work-up
Correlation of HER2-PET result (assessed about 1 week after scan) and standard conventional work-up (assessed before/at screening)
Time frame: about 2 years (end of study)
Correlation of HER2-PET results and HER-2 expression by CTCs
Correlation of HER2-PET result (assessed about 1 week after scan) and HER-2 expression by CTCs (blood for CTC analysis will be drawn at day of tracer injection, analysis within 3 days)
Time frame: about 2 years (end of study)
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