Breast Cancer

Patient Population

Main Criteria Only

• Patients with Stage III-IV breast cancer treated to:
  • No evidence of disease (NED), or
  • Stable bone only disease
• Breast cancer must be HER2 negative
• Patients must be at least 28 days post cytotoxic chemotherapy, systemic steroids, and/or monoclonal antibody therapy, prior to enrollment
• 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 Patients must have ECOG Performance Status Score of ≤ 1 (Appendix A)
• Adequate laboratory values
• Patients must be at least 18 years of age

• Up to 30

• To look at how safe STEMVAC is in patients with HER2 negative advanced stage breast cancer
• To look at the effect of STEMVAC on the immune system when given to patients with HER2 negative advanced stage breast cancer

• Eligible patients will assigned sequentially to one of three arms defined by vaccine dose.  At each dose-level, the 3rd patient enrolled will be at least 1 month from their last vaccination before any other patients are enrolled.

• STEMVAC vaccines will be given during Month 1, 2, and 3
• Follow-up visit during Month 4
• Booster STEMVAC vaccines given during Month 6 and Month 12
• Follow-up visit during Month 15

• Information on how the patient is doing will be obtained from patient’s primary oncologist twice a year for up to five years after Month 15

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

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

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

  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

  30

  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.

  ClinicalTrials.gov Identifier: NCT01922921