Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Read our disclaimer for details.
This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to MFDS.
Condition or disease
Before the approval of IBRANCE® in Korea, as a part of Risk Management Plan (RMP), which is required by Ministry of Food and Drug Safety (MFDS), safety and efficacy information of new medication will be provided at minimum 3000 subjects administered in the setting of routine practice during the initial 6 years after the approval.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Gender Based Eligibility:
Accepts Healthy Volunteers:
All subjects 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.
Women of 18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease).
ER+ and/or PgR+ tumor based on local laboratory results :test as per local practice
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.
Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information
Known hypersensitivity to letrozole or its excipients or to any CDK4/6 inhibitor excipients.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
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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Studies a U.S. FDA-regulated Drug Product:
Keywords provided by Pfizer:
Metastatic breast cancer, safety, ibrance
Additional relevant MeSH terms:
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Neoplasms by Site