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
Price :
$35
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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
- 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