Breast Cancer, Breast Cancer Triple Negative
Conditions
Keywords
Breast cancer, Breast cancer triple negative, Breast cancer HER2+, Flu vaccine, Intratumoral flu vaccine, Intratumoral vaccine
Brief summary
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.
Interventions
BIOLOGICALFluzone Quadrivalent
Successive cohorts of participants (3 participants per tumor type per cohort) will each be started on a fixed dose of the influenza vaccine. For the first cohort, patients will receive Fluzone Quadrivalent - (Sanofi Pasteur) - 60mcg/0.5mL (standard dose IT flu shot, or dose level 0) intratumorally on day -6 +/- 1 day and day 0 or 1. For the second cohort, patients will receive Fluzone High-Dose Quadrivalent - (Sanofi Pasteur) - 240mcg/0.7mL (high dose IT flu shot, or dose level 1) intratumorally on day -6 +/- 1 day and day 0 or 1. has context menu
Sponsors
Rush University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ECOG 0-2 * Patients must be planning to receive standard of car e neoadjuvant chemotherapy as defined by the most recent version of NCCN guidelines (www.nccn.org) * Patients must have histologically or cytologically confirmed invasive breast cancer that is either triple-negative or HER2+ (regardless of hormone receptor status)
Exclusion criteria
* Patients with any uncontrolled intercurrent illness. * Patients who have any underlying medical condition for which, in the investigator's opinion, participation would not be in the best interest of the participant * History of egg allergy * Patients currently on anticoagulant therapy, corticosteroids, or immunosuppressive agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the seasonal flu vaccine. * History of Guillain-Barré syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose- limiting toxicity (DLT) | 3 months post surgery | The primary objective of this trial is to assess the safety of intratumoral (IT) influenza vaccine administration in patients with breast cancer receiving neoadjuvant chemotherapy, by evaluating the percentage of patients experiencing dose- limiting toxicity (DLT). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRuta Rao, MD
Rush University Medical Center
Outcome results
None listed