Phase 1
Completed N=20
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients
Breast Neoplasms · Secondary · HER2 Positive Carcinoma of Breast
Source: ClinicalTrials.gov NCT01420146 ↗
Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Apr 2017
Primary outcomePrimary: 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 — 4; 5; 1; 10 Participants
Summary
Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
4; 5; 1; 10 | — |
| SECONDARY Time Activity Curve |
— | — |
| SECONDARY HER2 Extracellular Domain |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01420146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.