Molecular PD-L1 PET/CT Imaging with 89Zr-atezolizumab to Monitor Immune Responses in metastatic Triple Negative Breast Cancer
Key facts
- Where
- Solna, SvédországSee the site
- Phase
- 2. fázis
Where in Svédország
- Karolinska University HospitalSolna, SvédországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karolinska University Hospital
- Trial code
- EU 2022-500808-21-00
- Record updated
- 2022. december 5.
- Original description
To establish the statistical agreement (by means of Cohen’s kappa coefficient) between PD-L1 status by the experimental method (PET/CT with 89Zr-atezolizumab) and the current reference standard (IHC on a tumour biopsy or resection specimen).Read full original descriptionShow less
To establish the statistical agreement (by means of Cohen’s kappa coefficient) between PD-L1 status by the experimental method (PET/CT with 89Zr-atezolizumab) and the current reference standard (IHC on a tumour biopsy or resection specimen).
Inclusion: Patients with metastatic triple-negative breast cancer by pathological criteria: oestrogen receptor expression <10%, progesterone receptor (PR) expression <10%, HER2 negative, on the primary tumour or a metastatic biopsy; Measurable disease according to RECIST v1.1; At least one metastatic lesion accessible for biopsy; Deemed by treating physician as fit for systemic therapy according to study protocol; ECOG performance score 0 or 1; Age >18 years old; Adequate bone marrow, renal and hepatic functions; Able and willing to provide written informed consent.
Exclusion: Vaccination with a live vaccine within 30 days of the first dose of study treatment; Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomisation; Hypersensitivity to atezolizumab; Other malignancy diagnosed within the last five years; Uncontrolled hypertension, heart-, liver-, or kidney-diseases or other medical/psychiatric disorders; History of autoimmune disease; A known history of HIV infection, hepatitis B or hepatitis C infection or active tuberculosis; Patients in child-bearing age without adequate contraception; Contraindications for PET/CT as defined for clinical practice; Pregnancy or lactation.