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Cancer Vaccine

Intratumoral influenza vaccine for Breast Cancer

Phase 1

Recruiting

Led By Ruta Rao, MD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post surgery

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of giving two doses of flu vaccine directly into breast cancer tumors. The study will look at how the tumor and the body respond to the vaccine. The vaccine will

Who is the study for?

This trial is for women with triple-negative or HER2+ breast cancer who are about to start standard chemotherapy. They should be relatively active and able (ECOG 0-2) and have a confirmed diagnosis through tissue samples. The study excludes certain individuals, but the criteria aren't fully listed here.Check my eligibility

What is being tested?

The study tests injecting flu vaccine directly into breast cancer tumors before chemo starts. Participants will receive different doses of the vaccine in palpable or non-palpable tumors, administered by trained professionals using touch or ultrasound guidance.See study design

What are the potential side effects?

While specific side effects are not detailed here, typical reactions to vaccines like soreness at injection site, fever, fatigue may occur; plus potential local tumor response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose- limiting toxicity (DLT)

Side effects data

From 2020 Phase 3 trial • 2654 Patients • NCT04120194

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

NanoFlu

Fluzone Quadrivalent

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intratumoral influenza vaccineExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluzone Quadrivalent

2019

Completed Phase 3

~2660

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,483 Total Patients Enrolled

2 Trials studying Breast Cancer

52 Patients Enrolled for Breast Cancer

Ruta Rao, MDPrincipal InvestigatorRush University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the current clinical trial open for new participant enrollment?

"As per the information available on clinicaltrials.gov, this current medical trial is actively seeking participants. The study was initially made public on February 28th, 2024 and its most recent revision occurred on March 8th of the same year."

Answered by AI

What is the upper limit for the number of individuals enrolled in this research endeavor?

"Indeed, data from clinicaltrials.gov confirms that this investigation is presently seeking participants. It was initially listed on February 28th, 2024, and last revised on March 8th, 2024. The study aims to enroll a total of 18 individuals at one designated site."

Answered by AI

Has the Intratumoral influenza vaccine been sanctioned by the FDA?

"Given that this is a Phase 1 trial, the safety of the intratumoral influenza vaccine has been rated as 1 by our team at Power. This indicates minimal existing data on both its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ruta Rao 2024. "A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06229392.

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