Clinical Trial

A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study

Active, Not Recruiting Phase 2
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Summary
The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy \[paclitaxel\] and avelumab in treating a type of breast cancer called Hormone Receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 negative(HER2-) breast cancer, which is either locally advanced or has metastasized (cancer that has spread in your body). The study will investigate if pelareorep in combination with paclitaxel and avelumab is more effective than paclitaxel alone, or pelareorep and paclitaxel. The safety of the combination treatments will also be evaluated.
Protocol Amendment History 34 amendments
This ClinicalTrials.gov record has been amended 34 times since 2019-12-28; most recent amendment 2025-01-14.
Status change: Recruiting → Active, Not Recruiting 2022-08-10
Status change: Not Yet Recruiting → Recruiting 2020-06-24
Trial Details
NCT Number NCT04215146
Lead Sponsor Oncolytics Biotech
Collaborators: PrECOG, LLC.
Conditions Breast Cancer Metastatic
Enrollment 48 participants
Start Date 2020-06-10
Primary Completion 2022-08-01 (estimated)
Study Completion 2025-06 (estimated)
Updated on ClinicalTrials.gov 2025-01-16