NCT06229392

A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer

A Phase I Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Breast Cancer Triple Negative

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone 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

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-06-01
• Completion: 2027-12-31
• First posted: 2024-01-29
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study