Breast NeoplasmNCT03445637
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
An observational study of Breast Neoplasm, run by Pfizer at 1 site in South Korea.
Trial summary
This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS). Before the approval of IBRANCE® in Korea, as a part of Risk Management Plan (RMP), which is required by MFDS, safety and efficacy information of new medication will be… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- How many people
- 552 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Feb 2018to 13 Jul 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All participants enrolled should meet the usual prescribing criteria for IBRANCE® as per the Local Product Document (LPD) and should be entered into the study at the physician's discretion.
Who may be able to join
- Women of ≥18 years of age with proven diagnosis of advanced/metastatic breast cancer (locoregionally recurrent or metastatic disease).
- Estrogen Receptor+ (ER+) and/or Progesterone Receptor+ (PgR+) tumor based on local laboratory results (test as per local practice).
- Human Epidermal Growth Factor Receptor 2 -(HER2-) breast cancer based on local laboratory results (test as per local practice or local guidelines)
- Patients must be appropriate candidates for hormone therapy.
- 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.
- During the post marketing surveillance (PMS) period, patients who initially administer IBRANCE®
Who cannot join
- Known hypersensitivity to letrozole or its excipients or to any Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor excipients.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS).
Before the approval of IBRANCE® in Korea, as a part of Risk Management Plan (RMP), which is required by MFDS, safety and efficacy information of new medication will be provided at minimum 1,000 participants administered in the setting of routine practice during the initial 9 years after the approval.
- Conditions
- Breast Neoplasm
- Keywords
- Metastatic breast cancer, safety, ibrance
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events during first 3 months
This is a prospective, observational, non-interventional, multi-center study in which subjects will be administered as part of routine practice at Korean health care centers by accredited physicians.
Measured: 2018 ~ 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start8 Feb 2018
- Primary completion13 Jul 2025
- Study completion13 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 552 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
- NCT03445637
- Sponsor's protocol ID
- A5481065
- Other IDs
- NCT03445637
- Status last verified
- Nov 2025
- First submitted
- 31 Jan 2018
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
- ClinicalTrials.gov ID
- NCT03445637
- Acronym / sponsor ID
- A5481065
- Conditions
- Breast Neoplasm
- Keywords
- Metastatic breast cancer, safety, ibrance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 13 Jul 2025 (actual)
- Study completion
- 13 Jul 2025 (actual)
- First posted
- 26 Feb 2018 (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.
This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS).
Before the approval of IBRANCE® in Korea, as a part of Risk Management Plan (RMP), which is required by MFDS, safety and efficacy information of new medication will be provided at minimum 1,000 participants administered in the setting of routine practice during the initial 9 years after the approval.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants enrolled should meet the usual prescribing criteria for IBRANCE® as per the Local Product Document (LPD) and should be entered into the study at the physician's discretion.
Key inclusion criteria (6 listed)
- Women of ≥18 years of age with proven diagnosis of advanced/metastatic breast cancer (locoregionally recurrent or metastatic disease).
- Estrogen Receptor+ (ER+) and/or Progesterone Receptor+ (PgR+) tumor based on local laboratory results (test as per local practice).
- Human Epidermal Growth Factor Receptor 2 -(HER2-) breast cancer based on local laboratory results (test as per local practice or local guidelines)
- Patients must be appropriate candidates for hormone therapy.
- 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 (2 listed)
- Known hypersensitivity to letrozole or its excipients or to any Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor excipients.
- Pregnant women
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
Treatment-related adverse events during first 3 months
Time frame: 2018 ~ 2025
This is a prospective, observational, non-interventional, multi-center study in which subjects will be administered as part of routine practice at Korean health care centers by accredited physicians.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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 Neoplasm, run by Pfizer at 1 site in South Korea.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 24 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment-related adverse events during first 3 months (time frame: 2018 ~ 2025). 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 24 Nov 2025.