| Eligibility |
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
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