Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer - Female
- Breast Cancer Stage I
- Breast Cancer Stage II
- Breast Cancer Stage III
- Breast Cancer - Male
- HER2 Positive Breast Carcinoma
- HER2 Positive Breast Cancer
- Residual Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03384914
- Collaborators
- United States Department of Defense
- Investigators
- Principal Investigator: Hyo S. Han, M.D. H. Lee Moffitt Cancer Center and Research Institute