Search / Trial NCT06229392

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

Launched by RUSH UNIVERSITY MEDICAL CENTER · Jan 19, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Breast Cancer Breast Cancer Triple Negative Breast Cancer Her2+ Flu Vaccine Intratumoral Flu Vaccine Intratumoral Vaccine

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of giving a seasonal flu vaccine directly into the breast cancer tissue of patients with breast cancer, specifically those with triple-negative or HER2+ types. The goal is to see how the body and the tumor respond to the vaccine. If the tumor can be felt, a trained surgeon will administer the vaccine in an outpatient setting. If the tumor cannot be felt, it will be done using ultrasound guidance. The trial aims to enroll up to 18 women, who will receive different doses of the vaccine and will have samples taken from their blood and tumor to monitor their response.

To participate, women must be planning to receive standard chemotherapy for their breast cancer and have a confirmed diagnosis of either triple-negative or HER2+ breast cancer. They should be in generally good health and not have any serious medical conditions that would complicate their participation. Participants can expect to be involved in the study from one week before starting chemotherapy and continuing for three months after surgery, during which they will receive two doses of the vaccine and have regular check-ups to assess their health and response to the treatment.

Gender

ALL

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

Trial Officials

Ruta Rao, MD

Principal Investigator

Rush University Medical Center

About Rush University Medical Center

Rush University Medical Center is a leading academic medical institution located in Chicago, Illinois, dedicated to advancing healthcare through innovative research and clinical trials. As a sponsor of numerous clinical studies, Rush focuses on translating scientific discoveries into effective treatments and improving patient outcomes across a variety of medical disciplines. With a commitment to excellence in patient care, education, and research, Rush leverages its state-of-the-art facilities and a robust network of specialists to conduct comprehensive trials that adhere to the highest ethical and regulatory standards. Through collaboration with a diverse patient population, Rush aims to enhance the understanding of diseases and develop novel therapeutic strategies.

Locations

Chicago, Illinois, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0