HER2-positive Locally Advanced UnresectableNCT06873191
A Study to Learn More About Tukysa Once it is Out in the Korean Market
An observational study of HER2-positive Locally Advanced Unresectable and Metastatic Breast Cancer, run by Pfizer.
Trial summary
The objectives of the re-examination system in Korea is to re-confirm the clinical usefulness of the product through collecting, reviewing, identifying and verifying the safety and efficacy information about the product in general practice in Korea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Locally Advanced Unresectable, Metastatic Breast Cancer
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 May 2029
- Phase
- Observational
- 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
Study population: The study population for this study includes subjects aged 18 years or older who will be monitored for any adverse events during treatment with TUKYSA® Tablets and for 28 days following the cessation of treatment in the Republic of Korea.
Who may be able to join
- Patient who is treated with TUKYSA according to the current TUKYSA label for the approved indication.
- Patient who is treated with TUKYSA for the first time.
- Patient who is aged 18 or over.
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Who cannot join
- 1. Patients to whom TUKYSA is contraindicated as per the local labeling Note: The summary for any patients who are violated in the inclusion/exclusion criteria (i.e. protocol violation case) will be separately done if collected and described in the separate section of the report.
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: Post-Approval Safety Monitoring Program to Assess the Safety and Efficacy Profile of TUKYSA in Usual Practice
The objectives of the re-examination system in Korea is to re-confirm the clinical usefulness of the product through collecting, reviewing, identifying and verifying the safety and efficacy information about the product in general practice in Korea.
This surveillance is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws, the Regulations on Safety of Pharmaceuticals, etc. and the Re-examination Regulation for New Drugs and Others.
Read the detailed description
The purpose of this study is to understand the safety of Tukysa (Tucatinib hemiethanolate) once it is out in the Korean market. Tukysa will be given to participants aged 18 or over in Republic of Korea.
Surveillance Design Patients with the approved indication who are treated with TUKYSA within the local label will be enrolled.
Adverse Events (AEs) will be collected in the usual practice during administration and for 28 days following cessation of TUKYSA, and ORR will be evaluated through radiographic imaging in the usual practice. The total follow-up period will not exceed 1 year.
Safety
Through the evaluation the safety profile of TUKYSA including important identified risks, Important potential risks, missing information, which are defined about TUKYSA in table2, will be examined. Drug safety is evaluated through the following items:
Efficacy Drug efficacy will be evaluated through the BOR. The ORR which is defined as the proportion of the subjects in the analysis population who have best response as CR or PR will be presented.
Surveillance for long-term use The follow-up period for each patient will vary according to tumor response, treatment of TUKYSA and others. Any patients who are treated with TUKYSA for more than or equal to 180 days including dose interruption will be evaluated for surveillance for long-term use.
- Keywords
- safety
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The BOR from the start of treatment until progressive disease (PD)/recurrence will be recorded in the electronic Case Report Form as CR, PR, stable disease (SD), PD or Not Evaluable (NE).
The BOR will be defined the best overall response recorded from the start of treatment until PD/recurrence.
Measured: From Day 1 through Day 7 after administration. Administration and for 28 days following. The total follow-up period will not exceed 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Locally Advanced UnresectableStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 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
- NCT06873191
- Sponsor's protocol ID
- C4251017
- Status last verified
- Nov 2025
- First submitted
- 6 Mar 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Safety Monitoring Program to Assess the Safety and Efficacy Profile of TUKYSA in Usual Practice
- ClinicalTrials.gov ID
- NCT06873191
- Acronym / sponsor ID
- C4251017
- Keywords
- safety
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 12 Mar 2025 (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 objectives of the re-examination system in Korea is to re-confirm the clinical usefulness of the product through collecting, reviewing, identifying and verifying the safety and efficacy information about the product in general practice in Korea.
This surveillance is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws, the Regulations on Safety of Pharmaceuticals, etc. and the Re-examination Regulation for New Drugs and Others.
Detailed description
The purpose of this study is to understand the safety of Tukysa (Tucatinib hemiethanolate) once it is out in the Korean market. Tukysa will be given to participants aged 18 or over in Republic of Korea.
Surveillance Design Patients with the approved indication who are treated with TUKYSA within the local label will be enrolled.
Adverse Events (AEs) will be collected in the usual practice during administration and for 28 days following cessation of TUKYSA, and ORR will be evaluated through radiographic imaging in the usual practice. The total follow-up period will not exceed 1 year.
Safety
Through the evaluation the safety profile of TUKYSA including important identified risks, Important potential risks, missing information, which are defined about TUKYSA in table2, will be examined. Drug safety is evaluated through the following items:
Efficacy Drug efficacy will be evaluated through the BOR. The ORR which is defined as the proportion of the subjects in the analysis population who have best response as CR or PR will be presented.
Surveillance for long-term use The follow-up period for each patient will vary according to tumor response, treatment of TUKYSA and others. Any patients who are treated with TUKYSA for more than or equal to 180 days including dose interruption will be evaluated for surveillance for long-term use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population for this study includes subjects aged 18 years or older who will be monitored for any adverse events during treatment with TUKYSA® Tablets and for 28 days following the cessation of treatment in the Republic of Korea.
Key inclusion criteria (4 listed)
- Patient who is treated with TUKYSA according to the current TUKYSA label for the approved indication.
- Patient who is treated with TUKYSA for the first time.
- Patient who is aged 18 or over.
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Key exclusion criteria (1 listed)
- 1. Patients to whom TUKYSA is contraindicated as per the local labeling Note: The summary for any patients who are violated in the inclusion/exclusion criteria (i.e. protocol violation case) will be separately done if collected and described in the separate section of the report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective Response Rate (ORR)
Time frame: From Day 1 through Day 7 after administration. Administration and for 28 days following. The total follow-up period will not exceed 1 year.
The BOR from the start of treatment until progressive disease (PD)/recurrence will be recorded in the electronic Case Report Form as CR, PR, stable disease (SD), PD or Not Evaluable (NE). The BOR will be defined the best overall response recorded from the start of treatment until PD/recurrence.
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 17 Nov 2025.
- 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.
Related trials for HER2-positive Locally Advanced Unresectable
Not yet recruitingObservational study
Zolbetuximab and Other Cancer Treatments in People With Advanced Gastric or GEJ Cancer in Clinical Practice (RADIANCE)
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
Not yet recruitingObservational study
Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA
Esophageal Cancer, GastroEsophageal Cancer
RecruitingPhase 3
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Breast Neoplasms
RecruitingPhase 3
A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer
Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma
RecruitingPhase 1/2
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)
Breast Neoplasms, Breast Cancer
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?
An observational study of HER2-positive Locally Advanced Unresectable and Metastatic Breast 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 1 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 17 Nov 2025. 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.
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?
Objective Response Rate (ORR) (time frame: From Day 1 through Day 7 after administration. Administration and for 28 days following. The total follow-up period will not exceed 1 year.). 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 17 Nov 2025.