A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer
Reason given: Internal operational issues prevented the study site from opening to enrollment.
Key facts
- Where
- Chicago, United StatesSee the site
- Phase
- Phase 1
Where in United States
- Rush University Medical CenterChicago, United StatesNo longer taking part
Trial details
- Who runs it
- Rush University Medical Center
- Trial code
- NCT06229392
- Record updated
- 11 March 2026
- Original description
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.Read full original descriptionShow less
A Phase I Study to Evaluate the 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.
Inclusion: 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: Patients currently on anticoagulant therapy, corticosteroids, or immunosuppressive agents; 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; History of allergic reactions attributed to compounds of similar chemical or biologic composition to the seasonal flu vaccine; History of Guillain-Barré syndrome.