Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229392
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-01-05
Brief Title:
A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
A Phase I Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Surgeononcologist 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None