Examining Bioactivity of PVSRIPO in Invasive Breast Cancer

Inclusion Criteria

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