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

NCT03445637

Last updated date
Study Location
Pfizer Tower
Seoul, , , Korea, Republic of
Contact
1-800-718-1021

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By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasm
Sex
Female
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

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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
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
 (submitted: February 22, 2018)
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

  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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2020