Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 4:23 AM
Study NCT ID:
NCT04937660
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2021-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Patterns & Clinical Outcomes of Palbociclib Combinations in HR+HER2-MBC
Sponsor:
Pfizer
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECIOUS
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PRECIOUS | OTHER | Alias Study Number | View |