NCT04120246

Alpha-TEA and Trastuzumab for the Treatment of Refractory HER2+ Metastatic Breast Cancer

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

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Veana Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of alpha-TEA when given together with trastuzumab and to see how well they work for the treatment of HER2+ breast cancer that does not respond to treatment (refractory) and has spread to other places in the body (metastatic). Anti-cancer treatment, such as alpha-TEA, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Alpha-TEA may also alter cancer growth by stimulating the body's immune response against the tumor. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Giving alpha-TEA and trastuzumab may work better for the treatment of HER2+ refractory and metastatic breast cancer compared to usual treatment.

Detailed 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 of each cycle. 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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• HER2 Positive Breast Carcinoma
• Metastatic Breast Carcinoma
• Refractory Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Alpha-tocopheryloxyacetic Acid	Given PO
BIOLOGICAL	Trastuzumab	Given IV

Timeline

• Start date: 2020-04-08
• Primary completion: 2028-02-01
• Completion: 2030-02-01
• First posted: 2019-10-09
• Last updated: 2024-07-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study