RecruitingNCT06805812

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

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

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

3,500 participants

Start Date

May 1, 2023

Study Type

OBSERVATIONAL

Conditions

Breast Adenocarcinoma Breast Cancer Stage IV

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting clinical data to identify factors that predict how well people with advanced hormone-positive, HER2-negative breast cancer respond to a class of drugs called CDK4/6 inhibitors (such as palbociclib, ribociclib, or abemaciclib) when used as first-line treatment. **You may be eligible if...** - You have been diagnosed with advanced (metastatic or locally advanced) breast cancer that is hormone receptor-positive and HER2-negative - You are receiving or are a candidate to receive a CDK4/6 inhibitor combined with hormone therapy as your first treatment for advanced disease - You have at least 3 months of follow-up data from starting CDK4/6 inhibitor therapy **You may NOT be eligible if...** - You have less than 3 months of follow-up data since starting CDK4/6 inhibitor therapy - You received CDK4/6 inhibitors as a single agent (not combined with hormonal therapy) - You received CDK4/6 inhibitors as adjuvant treatment for early-stage breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPalbociclib

Administered in combination with endocrine therapy

DRUGRibociclib

Administered in combination with endocrine therapy

DRUGAbemaciclib

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

View Full Details on ClinicalTrials.gov

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NCT06805812

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