Breast Neoplasms Clinical Trial
— IJBMNZrT003Official title:
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients : Correlation With FDG-PET/CT and Anatomopathological Results
Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: 1. All patients selected for this imaging study are patients scheduled to start trastuzumab-based therapy for advanced HER2 positive breast cancer (This includes trastuzumab alone, trastuzumab + chemotherapy, trastuzumab + endocrine therapy). 2. Histologically confirmed HER 2 positive (defined as FISH amplification ratio more than 2.2) invasive carcinoma of the breast (primary tumor at diagnosis) with locally recurrent or metastatic disease. 3. Patients with FDG-PET positive metastatic lesions. 4. Brain metastases are allowed provided they are controlled and they are not the sole site of metastatic disease. 5. Patient planned to have metastatic site biopsy for HER2 status control. 6. Age = 18 years 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1 8. For women of childbearing potential a pregnancy test will be done and an agreement to use a highly-effective non hormonal form of contraception. 9. Agreement from the patient to participate in this imaging study and if indicated agreement to biopsy one or two accessible lesions. 10. Signed written informed consent (approved by the Ethics Committee) obtained prior to any study procedure Exclusion criteria: 1. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) 2. Pregnant or lactating women 3. Current known infection with HIV, HBV, or HCV 4. Known severe hypersensitivity to trastuzumab 5. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol 6. Patients with bone only metastases are not eligible 7. Psychiatric illness/social situations that would limit compliance with study requirements 8. Patients who received lapatinib within the 7 days prior to HER immunoPET/CT. |
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Belgium | Jules Bordet Institut | Brussels |
Lead Sponsor | Collaborator |
---|---|
Jules Bordet Institute |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Test the diagnostic accuracy of the HER2 imaging using the labelled monoclonal antibody trastuzumab by correlating the HER2 PET/CT imaging with the FDG-PET/CT and molecular characterization of tumor samples with discordant image findings | 1 year | No | |
Secondary | Time activity curve | Time activity curve of normal organ and tumor lesions: pharmacokinetic | blood sample at 5, 15, 30, 60 minutes, 1 day, 2 days and 4 or 6 days after tracer injection. Images : Day 0, Day 2 and Day 4 or 6 | No |
Secondary | HER2 Extracellular domain | evaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality | within 60 min before tracer injection | No |
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