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PVSRIPO for Triple Negative Breast Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn how the study drug called PVSRIPO works and to see how it affects breast cancer tumors.

What is the Condition Being Studied?

Triple Negative Breast Cancer

Who Can Participate in the Study?

Adult women who:
- Have stage II-IV triple negative breast cancer who are planning to have surgery
- Have had their last dose of chemotherapy at least 3 weeks before the vaccine

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

- Get a polio virus vaccine booster shot
- Have a biopsy of your tumor 7-10 days after the vaccination
- Have the study drug (PVSRIPO) injected directly into your breast tumor
- Have surgery to remove your tumor about 2 weeks after the PVSRIPO injection
- Have blood tests and stool sample collected for research

- Have follow-up contacts at 2 days, one month and 6 months after PVSRIPO injection

Study Details

Full Title
Examining Oncolytic Poliovirus Bioactivity in Tumor Tissue after Intratumoral Administration of PVSRIPO in Women with Triple Negative Breast Cancer
Principal Investigator
Surgical Oncologist
Protocol Number
IRB:PRO00085352
NCT:NCT03564782
Phase
Phase Pilot
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698