TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases
(TOPAZ Trial)

Recruiting in Palo Alto (17 mi)

Overseen byReva Basho, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Reva Basho

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a single arm, open label trial to assess the safety and efficacy of tucatinib in combination with pembrolizumab and trastuzumab for the treatment of HER2+ breast cancer brain metastases (BCBM). A total of 33 patients with untreated or previously treated and progressing HER2+ BCBM not requiring urgent central nervous system (CNS)-directed therapy will be enrolled. The study will determine the recommended dose of tucatinib in this combination and assess the efficacy of this combination in controlling CNS disease in patients with HER2+ BCBM.

Research Team

Reva Basho, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

Inclusion Criteria

HER2+ (as defined by ASCO/CAP clinical practice guideline) metastatic breast cancer.

Age ≥18 years.

ECOG performance status of 0-2.

See 4 more

Treatment Details

Interventions

Pembrolizumab (Monoclonal Antibodies)
Trastuzumab (Monoclonal Antibodies)
Tucatinib (Small Molecule Kinase Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Tucatinib + Pembrolizumab + TrastuzumabExperimental Treatment3 Interventions

Patients will receive a combination therapy of tucatinib with pembrolizumab and trastuzumab during the treatment period until progression, treatment intolerance, or patient withdrawal from study. Tucatinib and pembrolizumab are administered as experimental use while trastuzumab is administered per standard use. Patients are expected to be on treatment for at least 12 weeks.