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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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 (20)

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