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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04937660
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : April 21, 2023
Information provided by (Responsible Party):

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04937660

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

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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
King Hussein Cancer Center Recruiting
Amman, Jordan, 11941
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
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04937660    
Other Study ID Numbers: A5481150
PRECIOUS ( Other Identifier: Alias Study Number )
First Posted: June 24, 2021    Key Record Dates
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Middle East
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases