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Not recruiting
Phase 1

Influenza Vaccine

Sponsor:

Rush University Medical Center

Code:

NCT06229392

Conditions

Breast Cancer

Breast Cancer Triple Negative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluzone Quadrivalent

Study Details

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 ID

NCT06229392

Start date

Feb 28, 2024

Status verified date

Jun, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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-BarrĂ© syndrome

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intratumoral influenza vaccine

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

Primary outcome measure

  • Dose- limiting toxicity (DLT) [ Time Frame: 3 months post surgery ]

Central Contacts and Locations

Central contacts

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

More Information

Sponsor

Rush University Medical Center

Last update posted

Jun 26, 2024

Last verified

Jun, 2024

Keywords

  • Breast cancer
  • Breast cancer triple negative
  • Breast cancer HER2+
  • Flu vaccine
  • Intratumoral flu vaccine
  • Intratumoral vaccine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2024-06-26.