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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

Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 22 Jan 2025

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At a glance

  • Drugs Avelumab (Primary) ; Paclitaxel (Primary) ; Pelareorep (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms BRACELET-1
  • Sponsors Oncolytics Biotech
  • Most Recent Events

    • 14 Jan 2025 Planned primary completion date changed from 1 Jun 2022 to 1 Jun 2025.
    • 04 Oct 2024 According to a Oncolytics Biotech media release, recent clinical efficacy results from the BRACELET-1 trial in HR+/HER2- breast cancer pave the way for a clinical study designed to support an accelerated approval. the strong efficacy results from BRACELET-1 provide the foundation for a large Phase 2 study designed to support an accelerated approval.
    • 19 Sep 2024 According to a Oncolytics Biotech media release, BRACELET-1 study results substantiate the statistically significant near doubling of median overall survival observed in the earlier randomized IND-213 study in a similar patient population treated with pelareorep + chemotherapy compared to chemotherapy alone.

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