Clinical trial · Interventional
Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
NCT02286843CI-TRIAL-00052345completedN/AResults 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)
Some breast cancer cells make a protein called Human Epidermal Growth factor receptor 2 (HER2). Patients with HER2 positive (HER2+) breast cancer receive medicine that attacks HER2, which helps these patients live longer. Some HER2 negative (HER2-) breast cancer patients also benefit from medicines that attack HER2, but we do not know why or which patients will benefit. This study uses a new imaging method, HER2-targeted PET/CT, to identify patients that may benefit from medicines that attack HER2. This is experimental.
Conditions
Conditions (2)
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 Cancer Metastases | — | UNRESOLVED | — |
| HER2 Positive Breast | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr-pertuzumab | Radiation | — | UNRESOLVED |
| 89Zr-trastuzumab | Radiation | — | UNRESOLVED |
| PET/CT scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HER2-targeted PET/CT
- description
- Pts with confirmed HER2- breast cancer will then undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy. Avid lesions will be considered suspicious for HER2+ malignancy. Pts with at least one 89Zr-trastuzumab or 89Zr-pertuzumab avid lesion will be biopsied to confirm HER2+ pathology. From these 50 pts, we will determine the proportion of HER2- primary breast cancer pts that express HER2+ malignancy imagable by HER2-targeted PET/CT. Pts recruited to the protocol, but then drop out prior to HER2-targeted PET/CT due HER2+ disease being identified on retesting of the patient's archived tissue samples, will be replaced with newly recruited pts.
- interventionNames
- Radiation: 89Zr-trastuzumab
- Device: PET/CT scan
- Radiation: 89Zr-pertuzumab
Primary outcomes (1)
- measure
- Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women age \> 18 * Biopsy proven HER2 negative primary breast cancer and biopsy proven metastatic disease. * 5 or more foci of demonstrable metastases on recent imaging modalities (CT, MR, FDG PET/CT) * ECOG performance score of 0-2 Exclusion Criteria: * Life expectancy \< 3months * Pregnancy or lactation * Patients who cannot undergo PET/CT scanning because of weight limits * CNS only disease on recent imaging
References
Publications (2)
- DERIVEDUlaner GA, Carrasquillo JA, Riedl CC, Yeh R, Hatzoglou V, Ross DS, Jhaveri K, Chandarlapaty S, Hyman DM, Zeglis BM, Lyashchenko SK, Lewis JS. Identification of HER2-Positive Metastases in Patients with HER2-Negative Primary Breast Cancer by Using HER2-targeted 89Zr-Pertuzumab PET/CT. Radiology. 2020 Aug;296(2):370-378. doi: 10.1148/radiol.2020192828. Epub 2020 Jun 9. PMID 32515679
- DERIVEDUlaner GA, Hyman DM, Lyashchenko SK, Lewis JS, Carrasquillo JA. 89Zr-Trastuzumab PET/CT for Detection of Human Epidermal Growth Factor Receptor 2-Positive Metastases in Patients With Human Epidermal Growth Factor Receptor 2-Negative Primary Breast Cancer. Clin Nucl Med. 2017 Dec;42(12):912-917. doi: 10.1097/RLU.0000000000001820. PMID 28872549