NCT06525675

Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study)

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: Completed
• Phase: —
• Study type: Observational
• Enrollment: 419 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer
• Advanced Breast Cancer
• Luminal Breast Cancer
• HER2-negative Breast Cancer
• ER-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Fulvestrant Injectable Product	500 mg fulvestrant on days 1, 14, 28, and once monthly thereafter, administered intramuscularly.
DRUG	Letrozole 2.5mg	2.5 mg letrozole per day, administered orally (continuous treatment)
DRUG	Palbociclib 125mg	orally administration 125 mg palbociclib per day (in cycles of 3 weeks of treatment followed by 1 week off)

Timeline

• Start date: 2022-07-18
• Primary completion: 2024-05-26
• Completion: 2024-09-02
• First posted: 2024-07-29
• Last updated: 2024-12-13

Locations

36 sites across 6 countries: Czechia, France, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study