Alpha-TEA and Trastuzumab for the Treatment of Refractory HER2+ Metastatic Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8
- HER2 Positive Breast Carcinoma
- Metastatic Breast Carcinoma
- Prognostic Stage IV Breast Cancer AJCC v8
- Refractory Breast Carcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
OUTLINE: This is a dose-escalation study of alpha-TEA. Patients receive one of 4 doses of alpha-TEA orally (PO) on days 1-14. Patients also receive trastuzumab on day 1 of cycle 1 and then every 3 weeks per standard of care. Cycles repeat every 28 days in the absence of disease progression or unacce...
OUTLINE: This is a dose-escalation study of alpha-TEA. Patients receive one of 4 doses of alpha-TEA orally (PO) on days 1-14. Patients also receive trastuzumab on day 1 of cycle 1 and then every 3 weeks per standard of care. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 4 years.
Tracking Information
- NCT #
- NCT04120246
- Collaborators
- National Cancer Institute (NCI)
- Veana Therapeutics, Inc.
- Investigators
- Principal Investigator: William Gwin Fred Hutch/University of Washington Cancer Consortium
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