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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.
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.
Pertuzumab 420 mg IV will be given at the same time as trastuzumab.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Occurrence of Related Adverse Events (AEs)
Occurrence of AEs related to study treatment. Adverse Events will be graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE) V 4.02.
Time frame: 5 years
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