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

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NCT03445637

Last updated on June 8, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Tower
Seoul, , Korea, Republic of
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT03445637
Pfizer
Recruiting
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Ibrance®
This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to MFDS.
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.
Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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.
Breast Neoplasm
Not Provided
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
3000
April 30, 2022
December 31, 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03445637
A5481065
Not Provided
Not Provided
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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