Observational study on palbociclib combinations for metastatic breast cancer
Palbociclib Combinations in HR+/HER2- Metastatic Breast Cancer Patients: A Non-Interventional Prospective Study on the Treatment Patterns & Clinical Outcomes in Africa Middle East (PRECIOUS)
This study is looking at how well the combination of palbociclib with letrozole or fulvestrant works for people with HR+/HER2- metastatic breast cancer, while also collecting information about their experiences and health in Africa and the Middle East.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 12 sites (Alexandria and 11 other locations) |
| Trial ID | NCT04937660 on ClinicalTrials.gov |
What this trial studies
This observational multicenter study aims to gather prospective data on patients starting treatment with palbociclib in combination with letrozole or fulvestrant for HR+/HER2- metastatic or locally advanced breast cancer. The study will assess patient demographics, clinical characteristics, treatment history, and quality of life as part of routine clinical practice in Africa and the Middle East. Data will be collected through electronic case report forms, with investigators trained to ensure accurate documentation. The goal is to better understand treatment patterns and clinical outcomes in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with HR+/HER2- metastatic or locally advanced breast cancer who are initiating treatment with palbociclib.
Not a fit: Patients currently participating in interventional clinical trials or those receiving active treatment for other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of effective treatment patterns and improve clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
How similar studies have performed: While this study focuses on a specific regional population, similar observational studies have shown success in understanding treatment patterns and outcomes in breast cancer management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥18 years or older with diagnosis of adenocarcinoma of the breast with evidence of metastatic /locally advanced disease not amenable to treatment with curative intent. 2. Documented HR+ (ER+ and/or PR+) tumor based on local standards 3. Documented HER2- tumor based on local standards 4. Will initiate treatment with palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s), as first or second line therapy for metastatic/locally advanced BC at enrollment 5. Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits 6. 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 Exclusion Criteria: 1. Patients participating in any interventional clinical trial 2. Patients on active treatment for malignancies other than metastatic/locally advanced BC at the time of enrollment 3. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent
Where this trial is running
Alexandria and 11 other locations
- Alexandria School of Medicine/Clinical Research Center CRC — Alexandria, Egypt (Recruiting)
- Dar El Salam Oncology Hospital — Cairo, Egypt (Recruiting)
- National Cancer Institute — Cairo, Egypt (Recruiting)
- Ain Shams University Hospital — Cairo, Egypt (Recruiting)
- King Hussein Cancer Center — Amman, Jordan (Recruiting)
- American University of Beirut Medical Center — Beirut, Lebanon (Recruiting)
- Hôtel Dieu de France (HDF) — Beirut, Lebanon (Recruiting)
- Saint Joseph Hospital — Jdeidé - Metn, Lebanon (Recruiting)
- Hammoud Hospital University Medical Center (HHUMC) — Sidon, Lebanon (Recruiting)
- Hamad Medical Corporation — Doha, Qatar (Recruiting)
- King Fahad Specialist Hospital KFSH-Dammam — Dammam, Saudi Arabia (Recruiting)
- National Guard Hospital, Riyadh — Riyadh, Saudi Arabia (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.