Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study)
NCT Number: NCT06525675
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metastatic Breast Cancer|Advanced Breast Cancer|Luminal Breast Cancer|HER2-negative Breast Cancer|ER-positive Breast Cancer
Interventions: DRUG: Fulvestrant Injectable Product|DRUG: Letrozole 2.5mg|DRUG: Palbociclib 125mg
Sponsor: MedSIR
Collaborators: Pfizer
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 419
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-04-28
Completion Date: 2024-10
Locations: Onkologická klinika Fakultní nemocnice Olomouc, Olomouc, Czechia|General University Hospital in Prague, Praha, Czechia|Hopital Tenon, Paris, France|Hospital Europeo Georges Pompidou AP-HP, Paris, France|Institut Curie, Paris, France|Centre Paul Strauss, Strasbourg, 67000, France|Institut Universitaire du Cancer Toulouse, Toulouse, Toulouse, France|Klinikum Dessau (MVZ) - Frauenheilkunde, Dessau, Germany|Istituti Ospitalieri Cremona, Cremona, Italy|Instituto Europeo di Oncologia, Milano, 20141, Italy|Fondazione IRCCS Istituto Nazionale dei Tumori, Milano., Milan, Italy|Ospedale San Gerardo, Monza, Italy|Hospital Universitario Central de Asturias, Oviedo, Asturias, 33011, Spain|Hospital San Joan de Reus, Reus, Tarragona, Spain|Hospital Del Mar, Barcelona, 08003, Spain|Hospital Universitary Vall D´Hebron, Barcelona, 08035, Spain|Institut Català d' Oncologia L'Hospitalet (ICO), Barcelona, Spain|Institut Oncologic Baselga-Hospital Quiron Salud Barcelona, Barcelona, Spain|Hospital Universitario de Basurto, Bilbao, 48013, Spain|Hospital Provincial de Castellón, Castellón De La Plana, Spain|Hospital San Pedro Alcántara, Cáceres, Spain|Hospital Universitario Reina Sofía, Córdoba, 28091, Spain|ICO Girona, Girona, Spain|Hospital Universitario Juan Ramón Jiménez, Huelva, Spain|Hospital Universitario La Paz, Madrid, Spain|CHUS Complejo Hospitalario Universitario de Santiago, Santiago De Compostela, Spain|Hospital Universitario Virgen del Rocío, Sevilla, 41013, Spain|Fundación Instituto Valenciano de Oncología (IVO), Valencia, 46009, Spain|Hospital Arnau de Vilanova de Valencia, Valencia, Spain|Hospital Lozano Blesa, Zaragoza, 50009, Spain|Hospital Universitario Miguel Servet, Zaragoza, Spain|Royal United Hospitals Bath NHS Foundation Trust, Bath, United Kingdom|Barts Cancer Institute, London, United Kingdom|Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom|Abertawe Bro Morgannwg University Local Health Board, Singleton Hospital, Swansea, SA127BR, United Kingdom|Royal Cornwall Hospital NHS Trust, Truro, United Kingdom

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.

Primary Outcome Measures: 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, 24 months
Secondary Outcome Measures: 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, 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, 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, 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)., 24 months