About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of HR+/HER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and/or progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hybridization (ISH) analyses.
Have received or are candidate to receive treatment with palbociclib, ribociclib or abemaciclib in combination with endocrine therapy as first-line treatment for HR+/HER2- aBC.
Disqualifiers
Less than 3 months of follow up from the CDK4/6i start to the date of data cut-off;
Have received CDK4/6i as monotherapy;
Have received CDK4/6i as adjuvant treatment for localized disease.
Trial design
Treatments tested in this trial
- Palbociclib
- Ribociclib
- Abemaciclib
Treatment groups
Sponsors and collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
European Institute of Oncology, Italy
Collaborator
Humanitas Research Hospital IRCCS, Rozzano-Milan
Collaborator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborator
OSPEDALE ASST CREMONA
Collaborator
IOV Oncologico Veneto Padova
Collaborator
ASST Fatebenefratelli Sacco
Collaborator
IRCCS Fondazione Salvatore Maugeri, Pavia, Italy
Collaborator
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola
Collaborator
Azienda Ospedaliero-Universitaria di Modena
Collaborator
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Collaborator
A.O.U. Federico II, Napoli
Collaborator
San Raffaele University Hospital, Italy
Collaborator
Centro di Riferimento Oncologico - Aviano
Collaborator
Azienda Socio-Sanitaria Territoriale Lariana
Collaborator
Azienda ULSS 3 Serenissima, Ospedale di Mirano
Collaborator
Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma
Collaborator
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborator
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Azienda Ospedaliero-Universitaria Careggi
Collaborator
Humanitas, Istituto Clinico Catanese
Collaborator
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Collaborator
Fondazione Policlinico Universitario Campus Bio-Medico
Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborator