Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
NCT03445637
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1. Women of 18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease).
2. ER+ and/or PgR+ tumor based on local laboratory results :test as per local practice
3. HER2- breast cancer based on local laboratory results :test as per local practice or local guidelines
4. Patients must be appropriate candidates for hormone therapy.
5. 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.
1. Any patients who does not agree that Pfizer and companies working with Pfizer use
his/her information
2. Known hypersensitivity to letrozole or its excipients or to any CDK4/6 inhibitor
excipients.
3. Pregnant women
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Descriptive Information | |||||
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Brief Title | Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE® | ||||
Official Title | POST MARKETING SURVEILLANCE STUDY TO OBSERVE SAFETY AND EFFICACY OF IBRANCE(REGISTERED) | ||||
Brief Summary | This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to MFDS. | ||||
Detailed Description | 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. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Ecologic or Community Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | 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. | ||||
Condition | Breast Neoplasm | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment | 3000 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | April 30, 2022 | ||||
Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria
Exclusion Criteria
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03445637 | ||||
Other Study ID Numbers | A5481065 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | March 2021 |