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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 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.

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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.

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

FieldValue
Enrollment Target 31 participants
Start Date 2018-06-06
Est. Completion 2026-08-29
Phase Early Phase 1

What the Registry Record Tells You About NCT03387553

The ClinicalTrials.gov registry entry for NCT03387553 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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