NCT03445637Completed
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 552 (actual)
- First submitted
- 31 Jan 2018
- Start date
- 8 Feb 2018
- Primary completion date
- 13 Jul 2025
- Lead sponsor
- Pfizer
- Diseases
- Metastatic breast cancer
- NCT number
- NCT03445637
What you commit to
- Study type: Observational
- Participants enrolled: 552
- From 8 Feb 2018 to the primary completion date, 13 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known hypersensitivity to letrozole or its excipients or to any Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor excipients.
Other
- Pregnant women
Who the study is looking for
- 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®
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.