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Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Summary
PALMARES-2 is a retrospective/prospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+/HER2- aBC patients treated with first-line CDK4/6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4/6i as first-line of therapy for HR+/HER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.
Official title: Predictive Impact of Peripheral Blood Lymphocytes on clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
3500
Start Date
2023-05-01
Completion Date
2040-12-31
Last Updated
2025-02-03
Healthy Volunteers
No
Conditions
Interventions
Palbociclib
Administered in combination with endocrine therapy
Ribociclib
Administered in combination with endocrine therapy
Abemaciclib
Administered in combination with endocrine therapy
Locations (24)
Centro di Riferimento Oncologico IRCCS
Aviano, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili
Brescia, Italy
Humanitas Istituto Clinico Catanese
Catania, Italy
ASST Lariana - Ospedale Sant'Anna
Como, Italy
ASST Ospedale Maggiore
Cremona, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Ospedale San Martino
Genova, Italy
Istituto Tumori della Romagna IRST IRCCS
Meldola, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore
Milan, Italy
IEO Istituto Europeo di Oncologia
Milan, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Ospedale ASST Fatebenefratelli Sacco
Milan, Italy
ULSS 3 Veneto
Mirano, Italy
Azienda Ospedaliero-Universitaria
Modena, Italy
Azienda Ospedaliero-Universitaria Federico II
Naples, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy
Ospedale Maggiore della Carità
Novara, Italy
IOV Istituto Oncologico Veneto IRCCS
Padova, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
IRCCS - ICS Maugeri
Pavia, Italy
Clinica Ospedaliero - Universitaria Policlinico Umberto I
Roma, Italy
Policlinico Universitario Campus Bio-Medico
Roma, Italy
Policlinico Universitario Fondazione Agostino Gemelli
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy