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

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.

NCT Number	NCT06805812
Lead Sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Collaborators: European Institute of Oncology, Italy, Humanitas Research Hospital IRCCS, Rozzano-Milan, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, OSPEDALE ASST CREMONA, IOV Oncologico Veneto Padova, ASST Fatebenefratelli Sacco, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola, Azienda Ospedaliero-Universitaria di Modena, Azienda Ospedaliero Universitaria Maggiore della Carita, A.O.U. Federico II, Napoli, San Raffaele University Hospital, Italy, Centro di Riferimento Oncologico - Aviano, Azienda Socio-Sanitaria Territoriale Lariana, Azienda ULSS 3 Serenissima, Ospedale di Mirano, Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma, Fondazione IRCCS Policlinico San Matteo di Pavia, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Ospedaliero-Universitaria Careggi, Humanitas, Istituto Clinico Catanese, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Fondazione Policlinico Universitario Campus Bio-Medico, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions	Breast Adenocarcinoma, Breast Cancer Stage IV, Breast Cancer, Metastatic, Breast Carcinoma, Breast Diseases, Breast Neoplasms, Breast Neoplasms, Male, Breast Cancer +33 more
Enrollment	3,500 participants
Start Date	2023-05-01
Primary Completion	2030-12-31 (estimated)
Study Completion	2040-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-03