Protocol 146 - Alpha-TEA

A Phase I Dose Escalation Trial of Alpha-tocopheryloxyacetic Acid (α-TEA) in Patients with Treatment Refractory HER2+ Metastatic Breast Cancer

Study Contact:
Kellie Burton | 866.932.8588  206.616.9538|

Patient Population

Main Criteria Only

  • Patients with progressive HER2/neu overexpressing metastatic breast cancer, not considered curable by conventional therapies
    • HER2 positive defined per the 2018 ASCO/CAP Guidelines
    • Extra-skeletal disease that can be accurately measured ≥ 10mm by standard imaging techniques within 28 days of treatment
  • Patients must continue trastuzumab dosing per standard of care through the entire study period
  • Patients must have previously received trastuzumab/pertuzumab and TDM-1 in the metastatic setting
  • Patients must be at least 14 days post cytotoxic chemotherapy and/or immunosuppressants
  • Adequate labs within 28 days of first vaccination
  • Ability to swallow capsules
  • Cannot have history of active atrial fibrillation, supraventricular tachycardia and/or cardiac arrhythmia.
  • Cannot have active cardiac ischemia
  • Cannot have any clinically significant autoimmune disease requiring active treatment
  • Cannot have active brain metastatic disease

Number of Patients

Up to 24

Study Objectives

Primary objective

  • Determine the safety of 4 escalating doses of alpha-TEA therapy when combined with trastuzumab
  • Determine the clinical response rate of alpha-TEA therapy with trastuzumab

Secondary objective

  • Determine if concurrent alpha-TEA and trastuzumab increases the level of active effector memory T-cells at 4 escalating doses
  • Determine if concurrent alpha-TEA and trastuzumab increase the number of HER2-specific T cells at 4 escalating doses
  • Determine if the concurrent therapy modulates the level and function of (natural killer) NK cells

Exploratory objective

  • Evaluate if the presence of tumor infiltrating lymphocytes (TIL) is associated with clinical response to concurrent alpha-TEA and trastuzumab therapy

Treatment Information

Cycles 4-6: The dosing for cycles 4-6 will be the same as cycles 1-3 with repeat CT CAP prior to each 4th cycle. 

Study Location

University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195 Identifier: NCT04120246