Can Long-Term tucatinib use remain safe for HER2-Positive cancers?

NCT ID NCT07768358

NEW Not yet recruiting Disease control Sponsor: Pfizer Source: ClinicalTrials.gov โ†—

First seen Aug 17, 2026 ยท Last updated Aug 17, 2026

Summary

This study offers continued access to tucatinib, an oral targeted therapy, for people with HER2-positive cancers (including breast, cervical, and lung) who were already benefiting from the drug in a previous Pfizer-sponsored trial. The main goal is to monitor long-term safety and tolerability, tracking serious side effects and any reasons for stopping treatment. Participants will keep taking tucatinib twice daily while researchers collect additional safety data to better understand its profile over time.

What this could mean

Our plain-language read of the trial. This is informational only โ€” not medical advice or a prediction.

Active substance
tucatinib (TUKYSA), an oral targeted cancer drug taken twice daily
What this could lead to
If successful, this study could confirm the long-term safety of tucatinib for people with HER2-positive cancers, supporting its continued use as a maintenance therapy.
What could go wrong
This is an open-label continuation study without a comparison group, so it cannot prove effectiveness. Safety monitoring may reveal new side effects with longer use.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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