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Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Tower
Seoul, , Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasm
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT03445637
Pfizer
Not yet recruiting
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®

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Descriptive Information
Brief TitlePost Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
Official TitlePOST MARKETING SURVEILLANCE STUDY TO OBSERVE SAFETY AND EFFICACY OF IBRANCE(REGISTERED)
Brief SummaryThis non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to MFDS.
Detailed DescriptionBefore 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 TypeObservational
Study DesignObservational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationAll 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.
ConditionBreast Neoplasm
InterventionNot Provided
Study Groups/CohortsNot 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 StatusRecruiting
Estimated Enrollment
 (submitted: February 22, 2018)
3000
Original Estimated EnrollmentSame as current
Estimated Study Completion DateApril 30, 2022
Estimated Primary Completion DateApril 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria

  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.

Exclusion Criteria

  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
Sex/Gender
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03445637
Other Study ID NumbersA5481065
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description: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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2019

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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