drugset / Trial / NCT02336984

A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS

NCT02336984

NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. The target population is women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive. Participants will receive 6 vaccines along with 2 doses of trastuzumab. This study began at the Abramson Cancer Center of the University of Pennsylvania and will continue at H. Lee Moffitt Cancer Center and Research Institute.

Timeline

Start
2014-06
Primary completion
2016-04-04
Completion
2016-04-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza Virus Vaccine Vaccine
Subject Pertuzumab Monoclonal antibody 420 mg Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg

Indications