Clinical Drug Experience Knowledgebase

Criteria

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