Observing the safety and effectiveness of IBRANCE® in breast cancer patients
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
This study is testing how safe and effective IBRANCE® is for women with advanced breast cancer over nine years to ensure it works well in everyday treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 540 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT03445637 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor the safety and efficacy of IBRANCE® in women with advanced or metastatic breast cancer as part of a post-marketing surveillance commitment to the Ministry of Food and Drug Safety in Korea. The study will involve at least 1,000 participants who will receive IBRANCE® in routine clinical practice over a period of nine years following its approval. Participants must meet specific eligibility criteria, including being diagnosed with estrogen receptor-positive and/or progesterone receptor-positive breast cancer. The study will collect data on patient outcomes to ensure ongoing safety and effectiveness of the medication.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with a confirmed diagnosis of advanced or metastatic breast cancer who are suitable for hormone therapy.
Not a fit: Patients who are pregnant or have known hypersensitivity to letrozole or any CDK4/6 inhibitor are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and efficacy of IBRANCE® for patients with metastatic breast cancer.
How similar studies have performed: Other studies have shown success in monitoring the safety and efficacy of medications in similar patient populations, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Pfizer Tower — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.