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RECRUITING
NCT06805812

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Palbociclib

Administered in combination with endocrine therapy

DRUG

Ribociclib

Administered in combination with endocrine therapy

DRUG

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