Breast NeoplasmsNCT04982848
Korea Post Marketing Surveillance (PMS) Study of Talzenna®
An observational study of Breast Neoplasms, run by Pfizer.
Trial summary
Talzenna will be approved for the treatment of gBRCA advanced breast cancer in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Talzenna
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2027to 1 Nov 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Talzenna® is indicated as monotherapy for the treatment of adult patients with breast cancer susceptibility gene (BRCA) mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or advanced setting.
Who may be able to join
- Patient scheduled to start treatment with Talzenna® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (local label)
- 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
- Patients with known hypersensitivity to Talzenna®, or to any of the excipients.
- Breastfeeding
- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
About this study
Official title: A PROSPECTIVE, SINGLE-ARM, OPEN-LABEL, NON-INTERVENTIONAL, MULTI-CENTRE, POST MARKETING SURVEILLANCE (PMS) STUDY OF TALZENNA(REGISTERED)
Talzenna will be approved for the treatment of gBRCA advanced breast cancer in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Talzenna after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Talzenna will be observed.
- Conditions
- Breast Neoplasms
- Being tested
- Talzenna
- Keywords
- gBRCA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalzennaDrug
Talzenna treatment under Korea regulatory approval indication/dosage
| Study group | Role | What they receive |
|---|---|---|
| Talzenna treated group | Talzenna treated gBRCA Breast cancer patients in the real world setting in Korea Receives: Drug: Talzenna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events categorized according to physical organ and disease/symptom
It is non-interventional, observational study in the real world setting. Adverse events will be captured in the real world clinical practice.
Measured: From date of randomization until the 28 calendar days following the last administration of a drug under study
Secondary outcomes (1)
Overal response (Effectiveness outcome) by Response Evaluation Criteria In Solid Tumors (RECIST) critera
It is non-interventional, observational study in the real world setting. Response evaluation will be assessed based on the real world clinical practice
Measured: through study completion, an expected average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Jun 2027 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Why it stopped: Withdrawal of the marketing authorization for the breast cancer indication of Talzenna® in Korea, not related to safety concerns or any regulatory authority request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
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
- NCT04982848
- Sponsor's protocol ID
- C3441038
- Other IDs
- Talzenna PMS
- Status last verified
- Sep 2026
- First submitted
- 14 Jul 2021
- Last updated
- 14 Sep 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROSPECTIVE, SINGLE-ARM, OPEN-LABEL, NON-INTERVENTIONAL, MULTI-CENTRE, POST MARKETING SURVEILLANCE (PMS) STUDY OF TALZENNA(REGISTERED)
- ClinicalTrials.gov ID
- NCT04982848
- Acronym / sponsor ID
- C3441038
- Conditions
- Breast Neoplasms
- Keywords
- gBRCA
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Withdrawal of the marketing authorization for the breast cancer indication of Talzenna® in Korea, not related to safety concerns or any regulatory authority request
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 29 Jul 2021 (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.
Talzenna will be approved for the treatment of gBRCA advanced breast cancer in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Talzenna after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Talzenna will be observed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Talzenna treated group | – | Drug: TalzennaTalzenna treated gBRCA Breast cancer patients in the real world setting in Korea |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Talzenna® is indicated as monotherapy for the treatment of adult patients with breast cancer susceptibility gene (BRCA) mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or advanced setting.
Key inclusion criteria (2 listed)
- Patient scheduled to start treatment with Talzenna® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (local label)
- 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 (3 listed)
- Patients with known hypersensitivity to Talzenna®, or to any of the excipients.
- Breastfeeding
- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
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 |
|---|---|---|
| TalzennaTalzenna treatment under Korea regulatory approval indication/dosage | Drug | Talzenna treated group |
Primary outcome
Incidence of adverse events categorized according to physical organ and disease/symptom
Time frame: From date of randomization until the 28 calendar days following the last administration of a drug under study
It is non-interventional, observational study in the real world setting. Adverse events will be captured in the real world clinical practice.
1 secondary outcome
Overal response (Effectiveness outcome) by Response Evaluation Criteria In Solid Tumors (RECIST) critera
Time frame: through study completion, an expected average of 8 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 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. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, 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 2 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: withdrawn, as of the sponsor's last update on 14 Sep 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events categorized according to physical organ and disease/symptom (time frame: From date of randomization until the 28 calendar days following the last administration of a drug under study). 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 14 Sep 2026.