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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229392
• Other study ID #: 21083002
• Status: Recruiting
• Phase: Phase 1
• Start date: February 28, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Rush University Medical Center
• Contact: Angela Limburg, RN, BSN
• Phone: 312-942-3498
• Email: angela_d_limburg[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Triple Negative
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose- limiting toxicity (DLT)	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).	3 months post surgery