HER2-positive Breast CancerPhase 4NCT07768358
Tucatinib Continuation Study
A Phase 4 study testing tucatinib in people with HER2-positive Breast Cancer and Cervical Cancer, run by Pfizer.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer, Cervical Cancer, Biliary Tract Neoplasms
- What is being tested?
- tucatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2026to 13 Mar 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Agree to follow the reproductive criteria.
- Be willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in this protocol.
- Be capable of giving signed informed consent.
Who cannot join
- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
- Current use of any prohibited concomitant medications(s) or unwillingness or inability to use a required concomitant medication(s).
- Participants not previously enrolled or who have discontinued study intervention or who were randomized in the control arm in a Parent Study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: TUCATINIB CONTINUATION PROTOCOL: AN OPEN-LABEL STUDY FOR PARTICIPANTS FROM TUCATINIB CLINICAL STUDIES
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.
Read the detailed description
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.
- Conditions
- HER2-positive Breast Cancer, Cervical Cancer, Biliary Tract Neoplasms, Urothelial Cancer, Advanced Non-Small Cell Lung Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)
- Being tested
- tucatinib
- Keywords
- tucatinib
- Medical subject headings
- Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tucatinibDrug
Also called TUKYSA
150 - 300 mg, by mouth, twice a day
| Study group | Role | What they receive |
|---|---|---|
| tucatinib | Experimental | 150 - 300 mg, by mouth, twice a day Receives: Drug: tucatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To monitor the safety and tolerability of tucatinib
- Adverse events leading to permanent discontinuation of tucatinib
- All serious adverse events
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start6 Nov 2026 (estimated)
- Primary completion13 Mar 2032 (estimated)
- Study completion13 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768358
- Sponsor's protocol ID
- C4251014
- Other IDs
- 2025-524353-14-00, 2025
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TUCATINIB CONTINUATION PROTOCOL: AN OPEN-LABEL STUDY FOR PARTICIPANTS FROM TUCATINIB CLINICAL STUDIES
- ClinicalTrials.gov ID
- NCT07768358
- Acronym / sponsor ID
- C4251014
- Conditions
- HER2-positive Breast Cancer, Cervical Cancer, Biliary Tract Neoplasms, Urothelial Cancer, Advanced Non-Small Cell Lung Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)
- Keywords
- tucatinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2026 (estimated)
- Primary completion
- 13 Mar 2032 (estimated)
- Study completion
- 13 Mar 2032 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tucatinib | Experimental | Drug: tucatinib150 - 300 mg, by mouth, twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Agree to follow the reproductive criteria.
- Be willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in this protocol.
- Be capable of giving signed informed consent.
Key exclusion criteria (3 listed)
- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
- Current use of any prohibited concomitant medications(s) or unwillingness or inability to use a required concomitant medication(s).
- Participants not previously enrolled or who have discontinued study intervention or who were randomized in the control arm in a Parent Study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tucatinibAlso: TUKYSA150 - 300 mg, by mouth, twice a day | Drug | tucatinib |
Primary outcome
To monitor the safety and tolerability of tucatinib
Time frame: Up to approximately 5 years
* Adverse events leading to permanent discontinuation of tucatinib * All serious adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tucatinib in people with HER2-positive Breast Cancer and Cervical Cancer, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To monitor the safety and tolerability of tucatinib (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.