Can Long-Term tucatinib use remain safe for HER2-Positive cancers?
NCT ID NCT07768358
First seen Aug 17, 2026 · Last updated Aug 28, 2026 · Updated 2 times
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, 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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 175 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Be receiving tucatinib as a study intervention and deriving clinical benefit without evidence of disease progression (as determined by the investigator) in a tucatinib Parent Study. 2. Agree to follow the reproductive criteria. 3. Be willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in this protocol. 4. Be capable of giving signed informed consent. Exclusion Criteria: 1. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study. 2. Current use of any prohibited concomitant medications(s) or unwillingness or inability to use a required concomitant medication(s). 3. Participants not previously enrolled or who have discontinued study intervention or who were randomized in the control arm in a Parent Study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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