NCT01922921View on ClinicalTrials.gov

Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

February 5, 2014

Primary Completion Date

October 31, 2019

Study Completion Date

September 1, 2021

Conditions
HER2/Neu PositiveRecurrent Breast CarcinomaStage IV Breast Cancer
Interventions
BIOLOGICAL

HER-2/neu Intracellular Domain Protein

Given ID

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Pertuzumab

Given per standard of care

OTHER

Placebo

Given PO

BIOLOGICAL

Polysaccharide-K

Given PO

BIOLOGICAL

Trastuzumab

Given per standard of care

Trial Locations (1)

98109

Fred Hutch/University of Washington Cancer Consortium, Seattle

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

lead

University of Washington

OTHER

NCT01922921 - Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy | Biotech Hunter | Biotech Hunter