NCT03384914View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

February 19, 2018

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
Breast Cancer FemaleBreast Cancer, MaleBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage IIIResidual DiseaseHER2-positive Breast CancerHER2 Positive Breast Carcinoma
Interventions
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)."

Trial Locations (7)

14263

Roswell Park Comprehensive Cancer Center, Buffalo

30322

Emory - Winship Cancer Institute, Atlanta

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

43210

Ohio State University - Arthur G James Cancer Hospital & Richard J Solove Research Institute, Columbus

46202

Indiana University - Melvin and Bren Simon Cancer Center, Indianapolis

98109

University of Washington, Fred Hutchinson Cancer Research Center, Seattle

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT03384914 - Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer | Biotech Hunter | Biotech Hunter