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.
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 Type
OBSERVATIONAL
Enrollment
419
500 mg fulvestrant on days 1, 14, 28, and once monthly thereafter, administered intramuscularly.
2.5 mg letrozole per day, administered orally (continuous treatment)
orally administration 125 mg palbociclib per day (in cycles of 3 weeks of treatment followed by 1 week off)
Onkologická klinika Fakultní nemocnice Olomouc
Olomouc, Czechia
General University Hospital in Prague
Prague, Czechia
Hopital Tenon
Paris, France
Hospital Europeo Georges Pompidou AP-HP
Paris, France
Institut Curie
Paris, France
Centre Paul Strauss
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization until death from any cause in the palbociclib plus fulvestrant group versus the palbociclib plus letrozole group
Time frame: 24 months
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from randomization until objective tumor progression or death, as assessed by the investigator per RECIST v1.1, in the palbociclib plus fulvestrant group versus the palbociclib plus letrozole group
Time frame: 24 months
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization until death from any cause, in the palbociclib plus endocrine therapy (fulvestrant or letrozole) treated patients
Time frame: 24 months
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from randomization until objective tumor progression or death, as assessed by the investigator per RECIST v1.1, in the palbociclib plus endocrine therapy (fulvestrant or letrozole) treated patients
Time frame: 24 months
Number of patients with the same subsequent antineoplastic therapy
Number of patients with the same subsequent antineoplasic therapy is described as the number of patients with the same antineoplastic therapy administered after the end of the treatment with palbociclib combined with endocrine therapy (fulvestrant or letrozole).
Time frame: 24 months
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Strasbourg, France
Institut Universitaire du Cancer Toulouse, Toulouse
Toulouse, France
Klinikum Dessau (MVZ) - Frauenheilkunde
Dessau, Germany
Istituti Ospitalieri Cremona
Cremona, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Milan, Italy
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