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

Metastatic Breast Cancer Clinical Trial

— PRECIOUS  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937660
• Other study ID #: A5481150
• Secondary ID: PRECIOUS
• Status: Recruiting
• Start date: July 15, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2023
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: April 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Egypt,  Jordan,  Lebanon,  Qatar,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	The period from study entry until disease progression, or death	Baseline up to 24 months
Primary	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	Objective Response Rate	Tumor response to treatment; Complete response, partial response, or stable disease	2 years

External Links

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