Breast CancerNCT06735742
A Study to Learn About the Safety of TALZENNA for the Treatment of Breast Cancer
An observational study of Breast Cancer, run by Pfizer at 1 site in Japan.
Trial summary
The purpose of this study is to learn about the safety of TALZENNA for the patients with breast cancer that cannot be removed by surgery and has come back. These participants also have a past treatment with medicines that try to stop the growth of cancer cells. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 3 participants
- Where
- 1 siteJapan
- Study dates
- 12 Apr 2025to 30 Mar 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who satisfy the inclusion criteria
Who may be able to join
- Patients with BRCA mutation-positive and HER2- negative unresectable or recurrent breast cancer with a history of cancer chemotherapy
- No history of previous use of this drug
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TALZENNA Capsules Special Investigation - Investigation on BRCA Mutation-Positive and HER2-Negative Unresectable or Recurrent Breast Cancer With a History of Cancer Chemotherapy -
The purpose of this study is to learn about the safety of TALZENNA for the patients with breast cancer that cannot be removed by surgery and has come back. These participants also have a past treatment with medicines that try to stop the growth of cancer cells.
This study is seeking for participants who:
Read more
- have breast cancer that cannot be removed by surgery and has come back
- have not used this medicine before. All patients in this study will receive TALZENNA according to the prescriptions.
Patients will be followed up to 52 weeks (12 months) from the day of start of treatment start (Day 1). However, in cases where treatment has been completed or stopped less than 52 weeks (12 months) after the start of giving study medicine, the participants will be checked until completion (discontinuation) of treatment.
- Conditions
- Breast Cancer
- Keywords
- BRCA mutation-positive and HER2-negative, unresectable or recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions
For adverse drug reactions corresponding to myelosuppression, interstitial lung disease, thromboembolism, and secondary malignant tumour, the incidence, time of onset, grade, outcome etc. will be tabulated.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start12 Apr 2025
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 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
- NCT06735742
- Sponsor's protocol ID
- C3441045
- Status last verified
- Nov 2025
- First submitted
- 11 Dec 2024
- 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
- TALZENNA Capsules Special Investigation - Investigation on BRCA Mutation-Positive and HER2-Negative Unresectable or Recurrent Breast Cancer With a History of Cancer Chemotherapy -
- ClinicalTrials.gov ID
- NCT06735742
- Acronym / sponsor ID
- C3441045
- Conditions
- Breast Cancer
- Keywords
- BRCA mutation-positive and HER2-negative, unresectable or recurrent breast cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2025 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 16 Dec 2024 (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 study is to learn about the safety of TALZENNA for the patients with breast cancer that cannot be removed by surgery and has come back. These participants also have a past treatment with medicines that try to stop the growth of cancer cells.
This study is seeking for participants who:
- have breast cancer that cannot be removed by surgery and has come back
- have not used this medicine before. All patients in this study will receive TALZENNA according to the prescriptions.
Patients will be followed up to 52 weeks (12 months) from the day of start of treatment start (Day 1). However, in cases where treatment has been completed or stopped less than 52 weeks (12 months) after the start of giving study medicine, the participants will be checked until completion (discontinuation) of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who satisfy the inclusion criteria
Key inclusion criteria (2 listed)
- Patients with BRCA mutation-positive and HER2- negative unresectable or recurrent breast cancer with a history of cancer chemotherapy
- No history of previous use of this drug
Key exclusion criteria (1 listed)
- None
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
Incidence of adverse drug reactions
Time frame: Up to 52 weeks
For adverse drug reactions corresponding to myelosuppression, interstitial lung disease, thromboembolism, and secondary malignant tumour, the incidence, time of onset, grade, outcome etc. will be tabulated.
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.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Pfizer at 1 site in Japan.
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 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: under way, not looking for participants, 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.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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 drug reactions (time frame: Up to 52 weeks). 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.