Treatment Patterns & Clinical Outcomes of Palbociclib Combinations in HR+HER2-MBC (PRECIOUS)

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)

The objective of this non-interventional multicenter study is to provide prospective, observational data on patients initiating treatment with palbociclib combination to contribute to the knowledge of HR+ HER2-metastatic/locally advanced Breast Cancer (BC) disease management, its treatment pattern, clinical outcomes and quality of life (QoL) in the routine clinical practice in Africa and Middle East countries .

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer

Detailed Description

Patients with HR+/HER2- metastatic/locally advanced BC whose treatment decision with palbociclib has been made by their treating physician and who meet the eligibility criteria will be invited to participate in the study. Patients who 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 may be included in the study.

The variables assessed in this study will be patient demographics, clinical characteristics, comorbid conditions and concomitant medications, HR+ HER2-locally advanced and metastatic BC treatment history, current BC treatment, performance status (Eastern Cooperative Oncology Group (ECOG), clinical outcomes, and QoL. All assessments described in this protocol are performed as part of normal clinical practice or standard practice guidelines for the patient population and healthcare provider specialty in the countries where this non-interventional study is being conducted. All data collected in this study are intended to capture the real-world treatment patterns and outcomes for patients with HR+/HER2- metastatic/locally advanced BC. An electronic case report form (eCRF) will be used for data collection. Investigators will be trained with an initial on-site visit to the clinic on the protocol, electronic data capture (EDC) system (i.e., eCRF), investigator site master file (ISMF), documentation, and any applicable study processes. Any new information relevant to the performance of this non-interventional study (NIS) will be forwarded to the medical staff during the study. Remote data monitoring will be conducted during the life of the study to ensure timely reporting of safety data, data integrity and consistency.

• Study Type: Observational
• Enrollment (Actual): 185

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria School of Medicine/Clinical Research Center CRC
  • Cairo, Egypt, 11796
    • National Cancer Institute
  • Cairo, Egypt
    • Ain Shams University Hospital
  • Cairo, Egypt, 11745
    • Dar El Salam Oncology Hospital
• Jordan
  • Amman, Jordan, 11941
    • King Hussein Cancer Center
• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center
  • Beirut, Lebanon
    • Hôtel Dieu de France (HDF)
  • Jdeidé - Metn, Lebanon
    • Saint Joseph Hospital - Cancer Centers of Colorado
  • Sidon, Lebanon
    • Hammoud Hospital University Medical Center (HHUMC)
• Qatar
  • Doha, Qatar
    • Hamad Medical Corporation
• Saudi Arabia
  • Dammam, Saudi Arabia
    • King Fahad Specialist Hospital KFSH-Dammam
  • Riyadh, Saudi Arabia
    • National Guard Hospital, Riyadh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with HR+/HER2- metastatic/locally advanced Breast Cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	The period from study entry until disease progression, or death	Baseline up to 24 months
Overall Survival	Overall Survival is defined as the time from the date of start of palbociclib combination treatment till the date of death due to any cause.	Baseline up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	Tumor response to treatment; Complete response, partial response, or stable disease	2 years

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): April 29, 2025
• Study Completion (Actual): April 29, 2025

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Africa; Palbociclib; Middle East
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: A5481150; PRECIOUS (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No