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

Breast Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03445637
• Other study ID #: A5481065
• Status: Recruiting
• Start date: February 8, 2018
• Est. completion date: August 8, 2025

Study information

• Verified date: December 2022
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS).

Before the approval of IBRANCE® in Korea, as a part of Risk Management Plan (RMP), which is required by MFDS, safety and efficacy information of new medication will be provided at minimum 1,000 participants administered in the setting of routine practice during the initial 9 years after the approval.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 8, 2025
• Est. primary completion date: August 8, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Women of =18 years of age with proven diagnosis of advanced/metastatic breast cancer (locoregionally recurrent or metastatic disease).

• Estrogen Receptor+ (ER+) and/or Progesterone Receptor+ (PgR+) tumor based on local laboratory results (test as per local practice).

• Human Epidermal Growth Factor Receptor 2 -(HER2-) breast cancer based on local laboratory results (test as per local practice or local guidelines)

• Patients must be appropriate candidates for hormone therapy.

• 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.

• During the post marketing surveillance (PMS) period, patients who initially administer IBRANCE®

Exclusion Criteria

• Known hypersensitivity to letrozole or its excipients or to any Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor excipients.

• Pregnant women

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Pfizer Tower	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related adverse events during first 3 months	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.	2018 ~ 2025

External Links

•   To obtain contact information for a study center near you, click here.