Ignite Creation Date:
2024-05-06 @ 2:32 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02061423
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2014-02-10
Brief Title:
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer Post Neoadjuvant Chemotherapy
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Neoadjuvant
Brief Summary:
The primary goals of this trial will be to determine the safety and immune activity of HER-2 pulsed DC1 vaccine in patients with high risk HER-2pos breast cancer with residual disease post neoadjuvant therapy Investigators will also explore the possibility of determining whether circulating tumor cells can be used as surrogate to assess response to vaccination
Detailed Description:
Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses giving breast cancer specific immune cells greater opportunity to function while the immune repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the chance to test secondary prevention of breast cancer in high risk settings There is a need to determine whether this ICAIT DC1 can activate CD4 and CD8 T cells prior to or in combination with chemotherapy with or without added trastuzumab
This study began at the Abramson Cancer Center of the University of Pennsylvania and will be continued at H Lee Moffitt Cancer Center and Research Institute
This study began at the Abramson Cancer Center of the University of Pennsylvania and will be continued at H Lee Moffitt Cancer Center and Research Institute
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UPCC26113 | OTHER | CTSRMC Abramson Cancer Center University of Pennsylvania | None |