Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04767594
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2021-01-21
Brief Title:
First-line Palbociclib and Endocrine Therapy for Patients With HRHER2- Advanced Breast Cancer in the Real-world Setting
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
PERFORM An EPidEmiological PRospective Cohort Study to Generate Real-world Evidence in Patients With HRHER2- Advanced Breast Cancer Treated in the First Line Setting as Per Current Standard Of Care With an EndocRine-based Palbociclib CoMbination Therapy
Status:
RECRUITING
Status Verified Date:
2024-10
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:
PERFORM
Brief Summary:
This is a prospective single-arm multi-center observational non-interventional study NIS in Germany and Austria
Detailed Description:
Patients diagnosed with HRHER2- locally advanced or metastatic breast cancer indicated by their treating physicians for first line endocrine-based palbociclib combination therapy and who meet eligibility criteria will be invited to participate in this study The key objectives of this study are to describe clinical scientific and patient reported outcomes for patients with HRHER2- locally advanced or metastatic breast cancer initiating treatment with first line endocrine-based palbociclib combination therapy in the real-world setting in Germany and Austria Patient characteristics real-world treatment patterns treatment sequences and reasons for the physicians treatment decisions will be collected Additional real-world research questions are to explore patient-focused parameters such as longitudinal follow-up data on patient-reported outcomes beyond disease progression and by treatment sequence or to analyze the time from the start of first line treatment to the first administered palliative chemotherapy Clinical outcome by treatment sequences will be described Routinely assessed biomarkers and diagnostic procedures applied for treatment sequence decisions will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PERFORM-NIS | OTHER | Alias Study Number | None |