NCT01922921

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

Phase I/II Randomized Study of Combination Immunotherapy With or Without Polysaccharide Krestin (PSK®) Concurrently With a HER2 ICD Peptide-Based Vaccine in Patients With Stage IV Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase I/II trial studies the side effects of vaccine therapy with or without polysaccharide-K and to see how well it works in treating patients with stage IV human epidermal growth factor receptor 2 (HER2) positive breast cancer who are receiving HER2-targeted monoclonal antibody therapy. Vaccines made from HER2 intracellular domain (ICD) peptide may help the body build an effective immune response to kill tumor cells that express HER2. Polysaccharide-K may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy works better when given with or without polysaccharide-K in treating breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the safety of polysaccharide-K (PSK) when given with HER2-directed immunotherapy. SECONDARY OBJECTIVES: I. To evaluate the effect of PSK on natural killer (NK) cell functional activity when given with HER2-directed immunotherapy. TERTIARY OBJECTIVES: I. To investigate the effect of PSK when given with HER2-directed immunotherapy on: serum levels of pro-inflammatory cytokine and/or chemokines; intermolecular epitope spreading; serum transforming growth factor (TGF)-beta levels; progression free survival (PFS) and overall survival (OS). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive HER2 ICD peptide-based vaccine intradermally (ID) once monthly for 3 months, trastuzumab (or trastuzumab and pertuzumab) per standard of care, and placebo orally (PO) twice daily (BID) for 4 months. ARM II: Patients receive HER2 ICD peptide-based vaccine ID and trastuzumab (or trastuzumab and pertuzumab) as in Arm I and polysaccharide-K PO BID for 4 months. After completion of study treatment, patients are followed up for 9 months and then twice annually for 3 years.

Conditions

• HER2/Neu Positive
• Recurrent Breast Carcinoma
• Stage IV Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-02-05
• Primary completion: 2019-10-31
• Completion: 2021-09-01
• First posted: 2013-08-14
• Last updated: 2023-04-18
• Results posted: 2023-04-18

Locations

1 site across 1 country: United States