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NCT03387553 · ClinicalTrials.gov registry record · Early Phase 1
HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer
A Early Phase 1 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Early Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT03387553: Active Early Phase 1 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03387553 is a Early Phase 1 study of Breast Cancer and HER2-positive Breast Cancer that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 31 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03387553, a Early Phase 1 study of Breast Cancer and HER2-positive Breast Cancer, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to learn more about how to treat patients with HER-2/neu positive invasive breast cancer (IBC). HER-2/neu is a type of protein that is known to be over-expressed in aggressive breast cancer. The study drug for this trial is DC1 study vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. This study vaccine is made from the participant's blood cells collected from a procedure called leukapheresis. Dendritic cells are immune cells that can tell the immune system to fight infection. In laboratory testing and from previous studies in participants, these cells may also help the immune system attack tumors such as breast cancer.
Primary Outcome
Immunogenicity of HER2 DC Vaccine per treatment Arm, based on week 4 ELISPOTs. Three metrics of CD4+ Th1 response will be computed for each patient, (a) overall anti-HER2 responsivity (i.e., if patient demonstrates a positive ELISPOT response to \>1 peptide, (b) response repertoire (i.e., number of reactive peptides) and (c) cumulative response (total SFC/10\^6 cells across 6 peptides). The primary immunogenicity outcome will be the cumulative response at week 4 (week after completion of all vac
Conditions Studied
Interventions
- DRUG Neoadjuvant Chemotherapy
- BIOLOGICAL Dendritic Cell Vaccine (DC1)
- PROCEDURE Curative Surgery
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-06-06 |
| Est. Completion | 2026-08-29 |
| Phase | Early Phase 1 |
What the registry record for NCT03387553 still lists
NCT03387553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 8 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Neoadjuvant Chemotherapy is the first listed.
NCT03387553 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03387553 about?
NCT03387553 is a clinical study titled "HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer". The purpose of this study is to learn more about how to treat patients with HER-2/neu positive invasive breast cancer (IBC). HER-2/neu is a type of protein that is known to be over-expressed in aggressive breast cancer. The study drug for this trial is DC1 study vaccine which is a HER2-sensitized d...
What is the current status of trial NCT03387553?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 31 participants. The study started on 2018-06-06. Estimated completion is 2026-08-29.
What conditions does trial NCT03387553 study?
This clinical trial studies the following conditions: Breast Cancer, HER2-positive Breast Cancer, Breast Cancer Female, Stage II Breast Cancer, Invasive Breast Cancer.
What interventions are being tested in trial NCT03387553?
The interventions under investigation include: Neoadjuvant Chemotherapy (DRUG), Dendritic Cell Vaccine (DC1) (BIOLOGICAL), Curative Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03387553?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03387553 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03387553's enrollment target sits among peer trials
31 948th of 1224 higher than 271 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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