Status:
WITHDRAWN
TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases
Lead Sponsor:
Reva Basho
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Seagen Inc.
Conditions:
Breast Cancer
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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)...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- ECOG performance status of 0-2.
- HER2+ (as defined by ASCO/CAP clinical practice guideline) metastatic breast cancer.
- Untreated or previously treated and progressing CNS disease.
- Measurable CNS metastases.
- Must be able to undergo MRI of the brain.
- Adequate organ function.
Exclusion
- Any indication for immediate CNS-directed therapy.
- History of generalized or complex partial seizures.
- Any other manifestation of neurologic progression that in the opinion of the treating physician is due to brain metastases.
- Leptomeningeal disease.
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
- Prior therapy with tucatinib.
- Active autoimmune disease that has required systemic treatment in excess of prednisone 10mg daily or equivalent in the past 2 years.
- Complete inclusion/exclusion criteria are detailed in the protocol.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04512261
Start Date
June 1 2022
End Date
June 1 2024
Last Update
July 1 2022
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048