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Phase 3 study of REOLYSIN in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer (mBC) patients

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Trial Profile

Phase 3 study of REOLYSIN in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer (mBC) patients

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 07 Jun 2023

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At a glance

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

    • 05 Jun 2023 According to an Oncolytics Biotech media release, company is planning to discuss data from a phase II trial with the FDA to investigate incorporating dual PFS and OS endpoints into this breast cancer program. Including a PFS endpoint could substantially reduce the time to pivotal readout from this registrational trial.
    • 21 Mar 2019 According to an Oncolytics Biotech media release, pelareorep has received Fast Track designation for this trial from FDA for the treatment of metastatic breast cancer.
    • 10 May 2018 According to an Oncolytics Biotech media release, the company has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the company's phase 3 study evaluating pelareorep for the treatment of metastatic breast cancer
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