The purpose of this protocol is to give continued access to tucatinib eligible participants. It also enables ongoing safety follow-up for those who continue to benefit from the study treatment. These participants were part of Pfizer-sponsored tucatinib parent studies that will be closed. Additional follow-up safety information will be collected. This will allow further understanding of the safety profile of tucatinib in participants who continue to receive the study treatment.
The study is seeking participants who * continue to benefit without disease progression from tucatinib as judged by the treating physician. * are willing to follow protocol requirements. All participants in this study will receive tucatinib. Tucatinib will be taken by mouth 2 times a day. We will examine the experiences of people receiving the study medicine. This will help us assess if tucatinib is safe. Participants will stay in the study for up to 5 years or until tucatinib is permanently discontinued, whichever comes first. During this time, they will have one clinical visit every three weeks to receive the study treatment. They will also talk with the treating physician about their experiences.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
175
150 - 300 mg, by mouth, twice a day
To monitor the safety and tolerability of tucatinib
* Adverse events leading to permanent discontinuation of tucatinib * All serious adverse events
Time frame: Up to approximately 5 years
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