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

Phase 1

Recruiting

• Conditions: Breast Cancer Triple Negative; Breast Cancer
• Interventions: Biological: Fluzone Quadrivalent

• Registration Number: NCT06229392
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-29
• Study Start: 2024-02-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intratumoral influenza vaccine	Fluzone Quadrivalent	-

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States