breast cancer mamma carcinoma
Conditions
Interventions
Injection with the tracer 89Zr-trastuzumab and 89Zr-trastuzumab PET/CT four
days post injection.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. HER2-positivity is defined as: a) HER2 immunohistochemical score of 3+, or b) HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification. 2. Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma: a) in whom standard work up with imaging has failed to solve the clinical dilemma (diagnostic/therapeutic), leaving issues with regard to HER2 status of lesions and b) in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise. 3. Standard work-up with imaging is defined as CT chest and abdomen, bone scintigraphy, as well as FDG-PET. 4. Age >18 years of age. 5. WHO performance status 0-2.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are • Correlation of HER2-PET results and questionnaire results regarding clinical value of HER2-PET for the referring clinician • Correlation of HER2-PET results with standard conventional work-up • Correlation of HER2-PET results and HER-2 expression by CTCs. | — |
Countries
Netherlands
Outcome results
None listed