NCT02336984

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	HER-2 pulsed DC1	Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.
DRUG	trastuzumab	The loading dose of Trastuzumab will be 8 mg/kg and the maintenance dose given week 4 will be 6 mg/kg, both standard doses of trastuzumab.
DRUG	pertuzumab	Pertuzumab 420 mg IV will be given at the same time as trastuzumab.

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-04-04
• Completion: 2016-04-04
• First posted: 2015-01-13
• Last updated: 2021-01-11

Locations

2 sites across 1 country: United States