Overview - this study is not yet recruiting
The NIH/NCCAM is funding a clinical trial for breast cancer patients at Fred Hutchinson Cancer Research Center & University of Washington Cancer Consortium, in collaboration with researchers from Bastyr University. The purpose of the study is to test the safety and tolerability of consuming a mushroom supplement, and to detect its effect on immune function. The study uses a mushroom product that has been approved as a pharmaceutical drug in Japan—protein-bound polysaccharide K (PSK®, Krestin®). PSK has a long term (over 30 years) safety record and many positive results are indicated in uncontrolled trials. The design of this study is a double blind placebo, controlled for PSK, which is the gold standard for evidence-based medicine.
More specifically, this randomized phase I/II trial studies the side effects of vaccine therapy and trastuzumab with or without a mushroom extract, 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. Vaccines made from HER2 intracellular domain (ICD) peptide may help the body build an effective immune response to kill tumor cells that express HER2. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Polysaccharide-K may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy and trastuzumab is more effective when given with or without polysaccharide-K in treating breast cancer.
For healthcare providers and researchers:
You may be eligible if:
How To Participate: this study is not yet recruiting. Check the .gov link above for the status.
Contact Stephanie Parker, Tumor Vaccine Group Screening Coordinator for screening: