A Phase I Study to Evaluate the Safety of Intratumoral Influenza Vaccine Administration in Patients with Breast Cancer

This phase 1 study will assess the safety and efficacy (usefulness) of administering 2 doses of seasonal flu vaccine directly into breast cancer tissue (primary tumor), and will study the tumor and whole body response to the vaccine.

If the tumor is palpable (able to fee by touch), the vaccine will be administered by a surgeon/oncologist in the outpatient floor – both experienced and trained. If not palpable, the procedure will be done via guided ultrasound by our breast radiologist – both experienced and trained.

Women with triple-negative (TNBC) and HER2+ types of breast cancer will be eligible for enrollment. Up to 18 subjects may be enrolled at RUSH. Successive groups of 3 subjects per breast cancer type will be given increasing doses of vaccine. There are 3 potential dosing groups (half-dose, full dose, and high dose). Blood, stool (optional), and tumor tissue samples will be collected and tested. The active participation period is from one week prior to starting chemotherapy through three months post surgery.

In order to participate you must meet the following criteria:

• Have provision of signed and dated informed consent form.
• Are ≥18 years of age.
• Have an ECOG of 0-2.
• Have histologically or cytologically confirmed invasive breast cancer that is either:
  • Triple-negative (defined as ER < 10%, PR < 10%, and HER2-negative per ASCO CAP guidelines)
  • HER2+ (regardless of hormone receptor status)
• Are planning to receive standard of care neoadjuvant chemotherapy as defined by the most recent version of NCCN guidelines (www.nccn.org).
• Are capable of understanding and complying with the protocol and has signed the informed consent document.
• Have adequate hepatic function, as follows:
  • Aspartate aminotransferase(AST)≤2.5 x the upper limit of normal (ULN)per institutional values (if liver or bone metastases are present, ≤5x ULN)
  • Alanine aminotransferase(ALT)≤2.5 x ULN per institutional values (if liver or bone metastases are present, ≤5 x ULN)
  • Total bilirubin ≤1.5 x ULN per institutional values
• Have adequate renal function:
  • Serum creatinine £1.5 x ULN or calculated creatinine clearance of ≥ 60mL/min
• Have adequate cardiac left ventricular function, as defined by a left ventricular ejection fraction (LVEF) ³institutional standard of normal
• Have adequate bone marrow/hematological function for all the following criteria, as defined below:
  • Absolute neutrophil count ≥1500/mm3
  • Platelets ≥100,000/mm3
  • Hemoglobin ≥9 g/dL
• Have adequate pulmonary function as assessed by lack of pulmonary symptoms and normal physical examination.

You will be excluded from the study if any of the following criteria apply to you:

• Have any uncontrolled intercurrent illness.
• Have any underlying medical condition for which, in the investigator’s opinion, participation would not be in the best interest of the participant (e.g.- compromises the health of the subject) or that could prevent, limit or confound protocol assessments.
• Have history of egg allergy.
• Are currently on anticoagulant therapy, corticosteroids, or immunosuppressive agents.
• Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to the seasonal flu vaccine.
• Have a history of Guillain-Barré syndrome.
• Have unresolved adverse events grade two or higher from prior therapy according to CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5. 
• Have active infection requiring systemic therapy or causing fever (temperature > 38.1 ̊C) or subjects with unexplained fever (temperature > 38.1 ̊C) within 7 days prior to the day of investigational product administration. 
• Have received any live vaccines within 30 days prior to enrollment.
• The effects of intratumoral flu vaccine on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Patients who do not agree to comply with these precautions are ineligible.
• Are pregnant or nursing (breast-feeding) as there is an unknown but potential risk to multiple injections of flu vaccine in pregnant or nursing women.

NOTE: Previous treatment with flu vaccination is not an exclusion criterion. Routine intramuscular seasonal influenza vaccination is not required nor prohibited.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.