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Molecular PD-L1 PET/CT Imaging with 89Zr-atezolizumab to Monitor Immune Responses in metastatic Triple Negative Breast Cancer
EU CTIS ID: 2022-500808-21-00
What this study is testing
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).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Contraindications for PET/CT as defined for clinical practice.
- Hypersensitivity to atezolizumab.
- Other malignancy diagnosed within the last five years.
- Patients in child-bearing age without adequate contraception.
- Pregnancy or lactation.
- Uncontrolled hypertension, heart-, liver-, or kidney-diseases or other medical/psychiatric disorders.
See the full eligibility criteria
- 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
- Contraindications for PET/CT as defined for clinical practice.
- Hypersensitivity to atezolizumab.
- Other malignancy diagnosed within the last five years.
- Patients in child-bearing age without adequate contraception.
- Pregnancy or lactation.
- Uncontrolled hypertension, heart-, liver-, or kidney-diseases or other medical/psychiatric disorders.
- History of autoimmune disease.
- Vaccination with a live vaccine within 30 days of the first dose of study treatment
- A known history of HIV infection, hepatitis B or hepatitis C infection or active tuberculosis.
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomisation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.