Trials / Active Not Recruiting
Active Not RecruitingNCT03384914
Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Breast Cancer Female
- Breast Cancer, Male
- Breast Cancer Stage I
- Breast Cancer Stage II
- Breast Cancer Stage III
- Residual Disease
- HER2-positive Breast Cancer
- HER2 Positive Breast Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DC1 Vaccine | Vaccination Phase: DC1 vaccine will be administered weekly via intranodal injection in weeks 1 to 6 (window 8-21days between vaccines). Booster vaccines will be administered at approximately 3 month intervals on months 6, 9 and 12 (with a window +/- 1 month). |
| BIOLOGICAL | WOKVAC Vaccine | Vaccination Phase: WOKVAC vaccine will be administered via intradermal injection on weeks 1, 4 and 7 (window +21 days). Booster vaccines will be administered at approximately 3 month intervals on months 6, 9 and 12 (with a window +/- 1 month). |
Timeline
- Start date
- 2018-02-19
- Primary completion
- 2025-12-22
- Completion
- 2027-12-01
- First posted
- 2017-12-28
- Last updated
- 2026-03-06
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03384914. Inclusion in this directory is not an endorsement.