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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03445637
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to MFDS.

Condition or disease
Breast Neoplasm

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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: POST MARKETING SURVEILLANCE STUDY TO OBSERVE SAFETY AND EFFICACY OF IBRANCE(REGISTERED)
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Treatment-related adverse events during first 3 months [ Time Frame: 2018 ~ 2022 ]
    This is a prospective, observational, non-interventional, multi-center study in which subjects will be administered as part of routine practice at Korean health care centers by accredited physicians.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445637


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Korea, Republic of
Pfizer Tower Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03445637    
Other Study ID Numbers: A5481065
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (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/data_requests.

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Pfizer:
Metastatic breast cancer, safety, ibrance
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases