2022-500808-21-00CompletedPhase 2
Molecular PD-L1 PET/CT Imaging with 89Zr-atezolizumab to Monitor Immune Responses in metastatic Triple Negative Breast Cancer
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Dec 2022
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 14 Sept 2022
- Start date
- 1 Feb 2023
- Lead sponsor
- Karolinska University Hospital
- EU CT number
- 2022-500808-21-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 64
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Age
- Patients in child-bearing age without adequate contraception.
Other
- Contraindications for PET/CT as defined for clinical practice.
- Pregnancy or lactation.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska University Hospital | Solna | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.