TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases
Key facts
- Who runs it
- Reva Basho
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 1/2
- Started
- 1 Jun 2022
- Ended
- 1 Jun 2024
- Type of study
- Interventional
- Treatments tested
- Tucatinib
- Pembrolizumab
- Trastuzumab
- Record updated
- 1 July 2022
- Why it stopped
- Study withdrawn due to change in treatment landscape for HER2+ metastatic breast cancer.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Any indication for immediate CNS-directed therapy
- 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
- History of generalized or complex partial seizures
- Leptomeningeal disease
- 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
- Any other manifestation of neurologic progression that in the opinion of the treating physician is due to brain metastases
Where in United States
- Cedars-Sinai Medical CenterLos Angeles, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Tucatinib + Pembrolizumab + TrastuzumabTreatment being tested
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.
Treatment: Tucatinib, Pembrolizumab, and Trastuzumab
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- TOPAZ: Single Arm, Open Label Phase 1b/2 Study of Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases
- Record updated
- 1 July 2022