Clinical trial · Interventional
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients : Correlation With FDG-PET/CT and Anatomopathological Results
NCT01420146CI-TRIAL-00027049IJBMNZrT003completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| HER2 Positive Carcinoma of Breast | — | UNRESOLVED | — |
| Secondary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zr89-trastuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zr89-trastuzumab PET/CT
- description
- Zr89-trastuzumab PET/CT single arm
- interventionNames
- Drug: Zr89-trastuzumab
Primary outcomes (1)
- measure
- 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
- timeFrame
- 4 years
- description
- A visual 'patient-based' classification capturing the whole disease burden was developed by using a side-by-side display, comparing baseline FDG-PET/CT(showing all FDG-positive mets independent of their HER2-imaging status) \& day4 HER2-PET/CT. Pts were grouped into 4 HER2-PET/CT patterns according to the proportion of FDG avid tumour load showing relevant 89Zr-T uptake. Pattern A: entire tumor load showed pertinent tracer uptake; B: dominant part of tumour load showed tracer uptake; C: minor part of tumor load showed tracer uptake; D: entire tumor load lacked tracer uptake. Patterns A+B='HER2-positive' \& C+D='HER2-negative'. In the 20 pts: 4 pts were classified "A", 5"B", 1"C" \& 10"D". This classification indicates substantial heterogeneity of 89Zr-T uptake within this so called 'HER2-positive' pt population. After dichotomization, 11(55%) pts were considered as HER2-PET/CT negative. Furthermore, HER2-PET/CT revealed intrapatient heterogeneity of tumour uptake(pts classified B or C).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.