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

NCT ID: NCT06229392

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2027-12-31

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.

Conditions

Breast Cancer; Breast Cancer Triple Negative

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intratumoral influenza vaccine

Group Type: EXPERIMENTAL

Fluzone Quadrivalent

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ruta Rao

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruta Rao, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Central Contacts

Angela Limburg, RN, BSN

Role: CONTACT

angela_d_limburg@rush.edu

312-942-3498

Facility Contacts

Angela Limburg

Role: primary

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

21083002

Identifier Type: -

Identifier Source: org_study_id