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NCT00485277 · ClinicalTrials.gov registry record · Phase 1

A Safety and Immunology Study of a Modified Vaccinia Vaccine for HER-2(+) Metastatic Breast Cancer

A Phase 1 study of Breast Cancer, sponsored by Bavarian Nordic.

Completed
Registry status
Phase 1
Development phase
9
Enrollment target
2
Study locations

NCT00485277: Completed Phase 1 study of Breast Cancer, sponsored by Bavarian Nordic.

NCT00485277 is a Phase 1 study of Breast Cancer that has completed, run by Bavarian Nordic. The registered enrollment target is 9 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00485277, a Phase 1 study of Breast Cancer, has completed, sponsored by Bavarian Nordic.

COMPLETED
Registry status
Phase 1
Development phase
9 participants
Enrollment target
2
Study locations

Study Summary

The current trial, BNIT-BR-002, will evaluate the safety and biological activity of a fixed dose of MVA-BN®-HER2, with and without Herceptin, following 1st- or 2nd-line chemotherapy in patients with Her-2-positive metastatic breast cancer. The intent of vaccination is to induce anti-Her-2 immune responses, both antibody and T cell, that will then attack the Her-2 expressing tumors, and may induce tumor regression or slow progression of disease.

Conditions Studied

Breast Cancer

Interventions

  • BIOLOGICAL MVA-BN-HER2

Study Locations (2)

California

  • Alta Bates Herrick Hospital Comprehensive Cancer Center - Berkeley
  • Stanford Cancer Center - Stanford

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2007-06
Est. Completion 2010-09
Phase Phase 1

Sponsor

Bavarian Nordic

41 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00485277

The ClinicalTrials.gov registry entry for NCT00485277 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 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 (100% lower). The listed sponsor is Bavarian Nordic, which has 41 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which MVA-BN-HER2 is the first listed.

NCT00485277 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00485277 about?

NCT00485277 is a clinical study titled "A Safety and Immunology Study of a Modified Vaccinia Vaccine for HER-2(+) Metastatic Breast Cancer". The current trial, BNIT-BR-002, will evaluate the safety and biological activity of a fixed dose of MVA-BN®-HER2, with and without Herceptin, following 1st- or 2nd-line chemotherapy in patients with Her-2-positive metastatic breast cancer. The intent of vaccination is to induce anti-Her-2 immune re...

What is the current status of trial NCT00485277?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2007-06. Estimated completion is 2010-09.

What conditions does trial NCT00485277 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00485277?

The interventions under investigation include: MVA-BN-HER2 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00485277?

This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00485277 being conducted?

This trial has 2 study locations across California. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.