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

Launched by PFIZER · Feb 22, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a medication called IBRANCE® for women with advanced or metastatic breast cancer. It is a non-interventional study, meaning that researchers will observe how the medication works in real-life situations, without changing how doctors usually treat patients. The trial will include at least 1,000 women over the next nine years to gather important information that can help improve treatment options.

To participate in this study, women must be at least 18 years old and have a confirmed diagnosis of advanced breast cancer that is hormone receptor-positive and HER2-negative. Participants should also be eligible for hormone therapy. Before joining, each participant will sign a consent form to ensure they understand the study. While taking part in the trial, patients can expect regular check-ups to monitor their health and the medication’s effects. It’s important to note that women who are pregnant or have a known allergy to certain medications used in this study cannot participate.

Gender

FEMALE

Eligibility criteria

• • 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