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

Recruiting

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT04937660
• Lead Sponsor: Pfizer

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 .

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-06-24
• Study Start: 2021-07-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05
• Primary Completion: 2024-10-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Baseline up to 24 months	The period from study entry until disease progression, or death
Overall Survival	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

Name	Time	Method
Objective Response Rate	2 years	Tumor response to treatment; Complete response, partial response, or stable disease

Trial Locations

Locations (12)

Dar El Salam Oncology Hospital; 🇪🇬 Cairo, Egypt

National Cancer Institute; 🇪🇬 Cairo, Egypt

Hamad Medical Corporation; 🇶🇦 Doha, Qatar

National Guard Hospital, Riyadh; 🇸🇦 Riyadh, Saudi Arabia

Hôtel Dieu de France (HDF); 🇱🇧 Beirut, Lebanon

Alexandria School of Medicine/Clinical Research Center CRC; 🇪🇬 Alexandria, Egypt

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt

King Hussein Cancer Center; 🇯🇴 Amman, Jordan

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon

Saint Joseph Hospital; 🇱🇧 Jdeidé - Metn, Lebanon

Hammoud Hospital University Medical Center (HHUMC); 🇱🇧 Sidon, Lebanon

King Fahad Specialist Hospital KFSH-Dammam; 🇸🇦 Dammam, Saudi Arabia