Examining Bioactivity of PVSRIPO in Invasive Breast Cancer

This pilot study will include women with stage II-IV ER/PR/HER2 negative (triple negative) breast cancer scheduled to undergo surgical resection.

Inclusion Criteria

• Age ≥ 18 years
• Confirmation of invasive breast cancer including any of the following:
• Triple-negative breast cancer defined as receptor status being estrogen receptor expression ≤ 10%, progesterone receptor expression ≤ 10%, and HER2/Neu expression by IHC 0 or 1+, or 2+ with fluorescence in situ hybridization confirming no amplification of HER2 on a pretreatment tumor sample.
• Hormone positive breast cancer defined as receptor status being estrogen receptor expression > 10%, progesterone receptor expression > 10% prior to initiation of chemotherapy.
• HER2+ breast cancer defined as HER2/Neu expression by IHC 3+ or fluorescence in situ hybridization confirming amplification of HER2 on a pretreatment tumor sample prior to initiation of chemotherapy. HER2+ and hormone positive (ie triple positive) breast cancers are included in this study.
• Stage II-III invasive breast cancer with ≥ 1 cm of residual tumor based on MRI, mammogram, ultrasound, or breast clinical exam as SOC after completion of neoadjuvant chemotherapy, OR Stage IV BC with ≥ 1 cm locally recurrent disease (i.e. chest wall recurrence only)
• ECOG ≤ 1
• Hemoglobin ≥ 9.0 g/dl, ANC ≥ 1,500 cells/µl, platelets ≥ 100,000 cells/µl
• Women must have had last dose of chemotherapy at least 3 weeks prior to treatment with PVSRIPO
• Women must have at least 2 weeks minimum (ideal 3-4 weeks) of a wash-out period after any steroid administration (IV, PO, or intraocular)
• Serum creatinine ≤ 1.5 mg/dl, serum SGOT and bilirubin ≤ 1.5 times ULN (upper limit of normal)
• Women must provide written informed consent prior to enrollment on study, prior to conduct of screening procedures and enrollment on study
• Women of childbearing potential will have a negative serum pregnancy test at screening
• Women of childbearing potential must be willing to avoid pregnancy for the course of the study through 120 days after PVSRIPO injection
• Surgical resection of the tumor is planned and patient is willing to undergo surgical resection of the cancer

Exclusion Criteria

• T1 N0 invasive breast cancer
• Breast cancer with skin necrosis
• Concurrent immune therapy, chemotherapy, or steroid therapy
• Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to polio vaccine booster
• Has a known diagnosis of immunodeficiency
• Has a known additional malignancy that is progressing or requires active treatment
• Has known active central nervous system metastases and/or carcinomatous meningitis
• Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents
• Has an active infection requiring systemic therapy
• Has known psychiatric or substance abuse disorders that would interfere with the requirements of the trial
• Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 120 days after trial treatment
• Has received prior therapy with an anti-PD-1, anti-PDL-1, anti-PDL-2, anti-CD137, or anti-CTLA-4 (or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways)
• Has a known history of Human Immunodeficiency Virus (HIV)
• Has known active Hepatitis B or Hepatitis C
• Active liver disease with elevated transaminases > 2x ULN
• Has received a live vaccine within 30 days prior to PVSRIPO treatment
• Inactivated vaccines are acceptable and are not an exclusion criterion