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

NCT04937660 | Completed Results

• 2 other identifiers: A5481150PRECIOUS
• Study Type: observational
• Target: 185
• Locations: 5 countries
• Sites: 12

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 .

Conditions

Metastatic Breast Cancer

Keywords

Palbociclib; Africa; Middle East

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants Who Were Progression Free at 6 Months Post Palbociclib Initiation

  Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the electronic case report form (e-CRF). Kaplan-Meier method was used.

  At 6 months from the date of palbociclib initiation in routine clinical practice

• Percentage of Participants Who Were Progression Free at 12 Months Post Palbociclib Initiation

  Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used.

  At 12 months from the date of palbociclib initiation in routine clinical practice

• Percentage of Participants Who Were Progression Free at 18 Months Post Palbociclib Initiation

  Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used.

  At 18 months from the date of palbociclib initiation in routine clinical practice

• Percentage of Participants Who Were Progression Free at 24 Months Post Palbociclib Initiation

  Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used.

  At 24 months from the date of palbociclib initiation in routine clinical practice

• Percentage of Participants Who Were Alive at 1 Year Post Palbociclib Initiation

  Percentage of participants who were alive at 1 year post palbociclib initiation were reported in this outcome measure.

  At 1 year from the date of palbociclib initiation in routine clinical practice

• Percentage of Participants Who Were Alive at 2 Years Post Palbociclib Initiation

  Percentage of participants who were alive at 2 years post palbociclib initiation were reported in this outcome measure.

  At 2 year from the date of palbociclib initiation in routine clinical practice

Secondary Outcomes (24)

• Objective Response Rate (ORR)

  From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)

• Time From Initial Breast Cancer Diagnosis to Recurrence of Breast Cancer

  At baseline (prior to initiation of palbociclib treatment)

• Number of Participants According to Stage of Breast Cancer

  At baseline (prior to initiation of palbociclib treatment)

• Number of Participants According to Node Status

  At baseline (prior to initiation of palbociclib treatment)

• Number of Participants According to Menopausal Status

  At baseline (prior to initiation of palbociclib treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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

Sponsors & Collaborators

• Pfizer: lead

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

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 10, 2026
• Results First Posted: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1); QA (1); LE (4); SA (2); EG (4)