Protocol 135

Protocol 135: Phase I/II Randomized Study of Combination Immunotherapy With or Without Polysaccharide Krestin (PSK®) Concurrently with a HER2 ICD Peptide-Based Vaccine and Trastuzumab in Patients with Stage IV Breast Cancer

  Patient Population

  • Patients with Stage IV breast cancer treated to:
    • Complete remission, or
    • Stable bone only disease after finishing treatment
  • Breast cancer must be HER2+
  • Patients are expected to be on Trastuzumab (Herceptin) during the entire study period (one year)
  • Patients must be off  chemotherapy for  21 days before the enrolling into the study
  • Patients must be off  steroids for 14 days before enrolling into the study
  • Patients must be off any mushroom supplements (examples: turkey tail, reishi, maitake, shiitake,) for 28 days before joining the study and agree to withhold them for the entire study period (one year)
  • Patients may be taking bisphosphonates (examples: Zoledronic acid (Zometa), Alendronate sodium (Fosamax), Ibandronate (Boniva))  and/or endocrine (examples: Anastrazole (Arimidex), Exemestane (Aromasin), Fulvestrant (Faslodex)) therapy
  • Men and women must agree to use birth control if needed during the entire study period (one year)
  • Patients must be at least 18 years of age

  Number of Patients


  Study Objectives

  • To look at how safe PSK® (a natural mushroom product) is when given with HER2 peptide-based vaccine and Herceptin
  • To look at the effect of PSK® on the immune system when given with a HER2 peptide based vaccine and Herceptin

  Treatment Information

  Eligible patients will randomly assigned to one of  two treatment groups (15 patients per group):

  • Arm 1: HER2 vaccine + *Herceptin + Placebo tea
  • Arm 2: HER2 vaccine + *Herceptin + PSK® tea

 Patients and the study team will not be told which arm a patient is assigned to

*Patients will need to remain on their current regimen of Herceptin with their primary oncologist; this will not be provided by the study

  On-Site Study Visits

  • HER2 peptide vaccines will be given monthly for 3 months
  • Receive monthly supply of tea (PSK® or placebo) at each visit for 4 months
  • Follow-up visit: 1 month after last vaccine

  Long-term Follow-up

  • Follow-up research blood draws: 2 months and 9 months after the last vaccine - may be done at patient’s oncologist’s office
  • Information on how the patient is doing will be obtained from patient’s primary oncologist twice a year for up to three years

  Total Visits

  • 5 visits at the University of Washington Medical Center-Clinical Research Center

  Other Procedures During Study Visits

  • History and physicals
  • Tetanus vaccine at first visit only
  • Monthly pregnancy test if needed
  • Clinical blood tests plus research blood to do immune monitoring

  Study Location:

  University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195

  Related Publications

  Generation of T-cell immunity to the HER-2/neu protein after active immunization with HER-2/neu peptide-based vaccines.  

  Disis ML, Gooley TA, Rinn K, Davis D, Piepkorn M, Cheever MA, Knutson KL, Schiffman J Clin Oncol. 2002 June

  1;20(11):2624-32. Identifier: NCT01922921

Contact Information:



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