Clinical trial NCT04937660: Treatment Patterns & Clinical Outcomes of Palbociclib Combinations in HR+HER2-MBC
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Breast Cancer
Keywords: Palbociclib
Africa
Middle East
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-06-24
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HR+/HER2- metastatic/locally advanced Breast Cancer

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.

Eligibility 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: Baseline up to 24 months
measure: Overall Survival
timeFrame: Baseline up to 24 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria School of Medicine/Clinical Research Center CRC
city: Cairo
country: Egypt
facility: Dar El Salam Oncology Hospital
city: Cairo
country: Egypt
facility: National Cancer Institute
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
city: Amman
country: Jordan
facility: King Hussein Cancer Center
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Beirut
country: Lebanon
facility: Hôtel Dieu de France (HDF)
city: Jdeidé - Metn
country: Lebanon
facility: Saint Joseph Hospital
city: Sidon
country: Lebanon
facility: Hammoud Hospital University Medical Center (HHUMC)
city: Doha
country: Qatar
facility: Hamad Medical Corporation
city: Dammam
country: Saudi Arabia
facility: King Fahad Specialist Hospital KFSH-Dammam
city: Riyadh
country: Saudi Arabia
facility: National Guard Hospital, Riyadh
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: