NCT04937660

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 .

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
5 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2025

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

3.8 years

First QC Date

June 8, 2021

Last Update Submit

September 17, 2025

Conditions

Metastatic Breast Cancer

Keywords

PalbociclibAfricaMiddle East

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Objective Response Rate

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ≥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.
  • Documented HR+ (ER+ and/or PR+) tumor based on local standards
  • Documented HER2- tumor based on local standards
  • 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
  • Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits
  • 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

You may not qualify if:

  • Patients participating in any interventional clinical trial
  • Patients on active treatment for malignancies other than metastatic/locally advanced BC at the time of enrollment
  • Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Alexandria School of Medicine/Clinical Research Center CRC

Alexandria, Egypt

Location

Dar El Salam Oncology Hospital

Cairo, 11745, Egypt

Location

National Cancer Institute

Cairo, 11796, Egypt

Location

Ain Shams University Hospital

Cairo, Egypt

Location

King Hussein Cancer Center

Amman, 11941, Jordan

Location

American University of Beirut Medical Center

Beirut, Lebanon

Location

Hôtel Dieu de France (HDF)

Beirut, Lebanon

Location

Saint Joseph Hospital - Cancer Centers of Colorado

Jdeidé - Metn, Lebanon

Location

Hammoud Hospital University Medical Center (HHUMC)

Sidon, Lebanon

Location

Hamad Medical Corporation

Doha, Qatar

Location

King Fahad Specialist Hospital KFSH-Dammam

Dammam, Saudi Arabia

Location

National Guard Hospital, Riyadh

Riyadh, Saudi Arabia

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 24, 2021

Study Start

July 15, 2021

Primary Completion

April 29, 2025

Study Completion

April 29, 2025

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

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