Molecular PD-L1 PET/CT Imaging with 89Zr-atezolizumab to Monitor Immune Responses in metastatic Triple Negative Breast Cancer

Phase 1

• Conditions: Metastatic triple negative breast cancer; MedDRA version: 20.1Level: PTClassification code: 10055113Term: Breast cancer metastatic Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-500808-21-00
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion 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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified