A Phase 2 interventional study of 89Zr-trastuzumab injection in Metastatic Breast Cancer, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-05.
Sponsored by University Medical Center Groningen · Phase 2, Interventional, and Diagnostic
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 20 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
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Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. In the Netherlands HER2-positivity is defined as:
In Belgium HER2-positivity is defined as positive FISH for HER2/c-erbB2 amplification.
Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma:
Exclusion Criteria:
Injection of 89Zr-trastuzumab followed by PET scan
Drug: 89Zr-trastuzumab injection
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)
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen