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

• ClinicalTrials.gov Identifier: NCT04937660
• Recruitment Status: Recruiting
• First Posted: June 24, 2021
• Last Update Posted: April 21, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief 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 .

Condition or disease
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 Design

• Study Type: Observational
• Estimated Enrollment: 350 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: July 15, 2021
• Estimated Primary Completion Date: October 30, 2024
• Estimated Study Completion Date: April 30, 2025

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival [ Time Frame: Baseline up to 24 months ]
   The period from study entry until disease progression, or death
2. Overall Survival [ Time Frame: Baseline up to 24 months ]
   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.

Secondary Outcome Measures :

1. Objective Response Rate [ Time Frame: 2 years ]
   Tumor response to treatment; Complete response, partial response, or stable disease

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contacts and Locations

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Egypt

Alexandria School of Medicine/Clinical Research Center CRC; Recruiting

Alexandria, Egypt

Dar El Salam Oncology Hospital; Recruiting

Cairo, Egypt, 11745

National Cancer Institute; Recruiting

Cairo, Egypt, 11796

Ain Shams University Hospital; Recruiting

Cairo, Egypt

Jordan

King Hussein Cancer Center; Recruiting

Amman, Jordan, 11941

Lebanon

American University of Beirut Medical Center; Recruiting

Beirut, Lebanon

Hôtel Dieu de France (HDF); Recruiting

Beirut, Lebanon

Saint Joseph Hospital; Recruiting

Jdeidé - Metn, Lebanon

Hammoud Hospital University Medical Center (HHUMC); Recruiting

Sidon, Lebanon

Saudi Arabia

King Fahad Specialist Hospital KFSH-Dammam; Recruiting

Dammam, Saudi Arabia

National Guard Hospital, Riyadh; Recruiting

Riyadh, Saudi Arabia

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04937660
• Other Study ID Numbers: A5481150; PRECIOUS ( Other Identifier: Alias Study Number )
• First Posted: June 24, 2021
• Last Update Posted: April 21, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

Palbociclib; Africa; Middle East

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases