drugset / Trial / NCT00485277

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

NCT00485277 ↗

Phase 1 Completed 9 enrolled Bavarian Nordic
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-06
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject MVA-BN®-HER2 Vaccine — Subcutaneous

Indications