Status:
COMPLETED
Clinical Value of 89Zr-trastuzumab PET
Lead Sponsor:
University Medical Center Groningen
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. In the Netherlands HER2-positivity is defined as:
- HER2 immunohistochemical score of 3+, or
- HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification.
- 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:
- 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
- in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise.
- Standard work-up with imaging is defined as CT chest and abdomen, bone scintigraphy, as well as FDG-PET.
- Age \>18 years of age.
- WHO performance status 0-2.
- Signed written informed consent.
- Able to comply with the protocol.
Exclusion
- Pregnant or lactating women.
- Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
- Inability to comply with study procedures
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01832051
Start Date
March 1 2013
End Date
October 1 2015
Last Update
November 5 2015
Active Locations (1)
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1
University Medical Center
Groningen, Netherlands