Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525675
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Study to Evaluate the Extended Overall Survival OS Data From PARSIFAL Study The PARSIFAL-LONG Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study to Evaluate the Extended Overall Survival From PARSIFAL Trial Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patient With HER2-ER Metastatic Breast Cancer The PARSIFAL-LONG Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to evaluate the extended Overall Survival OS from PARSIFAL trial - NCT02491983 focused on the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with Human Epidermal growth factor Receptor 2 HER2-negative Endocrine Receptor ER-positive metastatic breast cancer It was designed to test the superiority of fulvestrant plus palbociclib compared with letrozole plus palbociclib first and then the non-inferiority of fulvestrant plus palbociclib compared with letrozole plus palbociclib if the superiority objective was not achieved
Detailed Description:
This is an observational international multi-center study with the objective to evaluate the extended overall survival from PARSIFAL trial NCT02491983 analyzing the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with HER2-negative ER-positive locally advanced or metastatic breast cancer The patients included in this trial were previously randomized in PARSIFAL trial and did not withdraw consent to participate in the PARSIFAL clinical trial The primary objective is to compare the efficacy in terms of OS of palbociclib in combination with fulvestrant interventional arm versus palbociclib plus letrozole control arm during extended follow-up of PARSIFAL trial and the secondary objectives are to assess the extended efficacy of palbociclib combined with fulvestrant or letrozole in terms of progression-free survival PFS to estimate the extended efficacy of palbociclib combined with endocrine therapy fulvestrant or letrozole in terms of OS and PFS and to assess the subsequent antineoplastic therapies to palbociclib combined with fulvestrant or letrozole in this population The PARSIFAL-LONG study is non-interventional There are no protocol-mandated visits or procedures associated with the study In this study the data required to document the defined study endpoints will be collected using the medical histories of patients accrued in the PARSIFAL study as data source This additional data will be analyzed along with the database of PARSIFAL trial The estimated study duration is 24 months and the expected period for data validation analysis and reporting is around 4 more months
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