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Brief Title: A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
Official Title: A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
Study ID: NCT02336984
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Name: Brian Czerniecki, M.D., Ph.D.
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: PRINCIPAL_INVESTIGATOR