Status:
COMPLETED
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
Lead Sponsor:
Pfizer
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 13 2025
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT03445637
Start Date
February 8 2018
End Date
July 13 2025
Last Update
November 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer
Seoul, South Korea