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Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer

Breast Cancer Female Clinical Trial

Official title:
A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer

Clinical Trial Summary

The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival). Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.

Clinical Trial Description

The total duration of the study will be 6 years (4 years of patient enrollment and 2 additional years of clinical follow-up). Assessment for disease recurrence and survival will be conducted every 6 months (with a phone call/secure email, medical records or follow up visit) from the end of treatment for a total of 2 years, until the completion of the trial or until documented disease recurrence. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03384914
Study type Interventional
Source H. Lee Moffitt Cancer Center and Research Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 19, 2018
Completion date December 2026
View Details
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