Status:
COMPLETED
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients
Lead Sponsor:
Jules Bordet Institute
Conditions:
Breast Neoplasms
Secondary
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab.
Detailed Description
This is the first belgian feasibility study of HER2 imaging using a labelled monoclonal antibody, namely trastuzumab labelled with zirconium 89. The aims of this study are: I/ Evaluate the diagnosti...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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).
- 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.
- Patients with FDG-PET positive metastatic lesions.
- Brain metastases are allowed provided they are controlled and they are not the sole site of metastatic disease.
- Patient planned to have metastatic site biopsy for HER2 status control.
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1
- For women of childbearing potential a pregnancy test will be done and an agreement to use a highly-effective non hormonal form of contraception.
- Agreement from the patient to participate in this imaging study and if indicated agreement to biopsy one or two accessible lesions.
- Signed written informed consent (approved by the Ethics Committee) obtained prior to any study procedure
- Exclusion criteria:
- Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
- Pregnant or lactating women
- Current known infection with HIV, HBV, or HCV
- Known severe hypersensitivity to trastuzumab
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- Patients with bone only metastases are not eligible
- Psychiatric illness/social situations that would limit compliance with study requirements
- Patients who received lapatinib within the 7 days prior to HER immunoPET/CT.
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01420146
Start Date
August 1 2011
End Date
September 1 2015
Last Update
April 18 2017
Active Locations (1)
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1
Jules Bordet Institut
Brussels, Brussels Capital, Belgium, 1000