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
Recruiting · NCT06805812 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
24 locations listed.
- 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