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Studies

Observational Recruiting

NCT06805812 on ClinicalTrials.gov

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

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

Brief 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.

Conditions

  • Breast Adenocarcinoma
  • Breast Cancer Stage IV
  • Breast Cancer, Metastatic
  • Breast Carcinoma
  • Breast Diseases
  • Breast Neoplasms
  • Breast Neoplasms, Male
  • Breast Cancer
  • Breast Cancer With Metastatic Bone Disease
  • Breast Cancers
  • Breast Neoplasm
  • Breast Tumors
  • HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer
  • HR+ Advanced or Metastatic Breast Cancer
  • HR+/HER2- Breast Cancer
  • HRpos Breast Neoplasms
  • HR-positive, HER2-negative Advanced Breast Cancer
  • HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer
  • HR-positive Breast Cancer
  • Hormone Receptor-Positive Breast Cancer
  • Hormone Receptor Positive Breast Adenocarcinoma
  • Hormone Receptor Positive Breast Carcinoma
  • Hormone Receptor Positive Breast Neoplasms
  • Hormone Receptor Positive HER-2 Negative Breast Cancer
  • Hormone Receptor Positive Malignant Neoplasm of Breast
  • Hormone Receptor Positive Metastatic Breast Cancer
  • Hormone Receptor Positive, HER2 Negative Breast Cancer
  • Hormone Receptor Negative Breast Cancer
  • Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
  • Hormone Receptor Positive Breast Cancer
  • Hormone Receptor Positive (ER+/PR+, and Her2-) Metastatic Breast Cancer
  • Hormone Receptor Positive, HER2-negative Neoplasms
  • Hormone Receptor Positive, HER2-low Neoplasms
  • Hormone Receptor Positive (HR+), HER2-negative Breast Cancer
  • Hormone Receptor (HR)-Positive Breast Cancer
  • Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer
  • Palbociclib
  • Ribociclib
  • Abemaciclib
  • CDK4/6 Inhibitor
  • CDK4/6 Inhibitors

Intervention / Treatment

  • Drug: Palbociclib
  • Drug: Ribociclib
  • Drug: Abemaciclib

Primary Outcome Measures

  • Overall Survival (OS) (From the first-line treatment start to date of any-cause death or last follow up, up to 120 months)

Countries

Italy

Locations and Investigators

  • Centro di Riferimento Oncologico IRCCS, Aviano, Italy (Recruiting)
    • Lorenzo Gerratana
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili, Brescia, Italy (Recruiting)
    • Rebecca Pedersini
  • Humanitas Istituto Clinico Catanese, Catania, Italy (Recruiting)
    • Paolo Vigneri
  • ASST Lariana - Ospedale Sant'Anna, Como, Italy (Recruiting)
    • Monica Giordano
  • ASST Ospedale Maggiore, Cremona, Italy (Recruiting)
    • Daniele Generali
  • Azienda Ospedaliero Universitaria Careggi, Firenze, Italy (Recruiting)
    • Icro Meattini
  • Ospedale San Martino, Genova, Italy (Recruiting)
    • Matteo Lambertini
  • Istituto Tumori della Romagna IRST IRCCS, Meldola, Italy (Recruiting)
    • Marianna Sirico
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore, Milano, Italy (Recruiting)
  • IEO Istituto Europeo di Oncologia, Milano, Italy (Recruiting)
  • IRCCS Ospedale San Raffaele, Milano, Italy (Recruiting)
    • Marta Piras
  • Ospedale ASST Fatebenefratelli Sacco, Milano, Italy (Recruiting)
    • Nicla La Verde
  • ULSS 3 Veneto, Mirano, Italy (Recruiting)
    • Donata Sartori
  • Azienda Ospedaliero-Universitaria, Modena, Italy (Recruiting)
    • Angela Toss
  • Azienda Ospedaliero-Universitaria Federico II, Napoli, Italy (Recruiting)
    • Mario Giuliano
  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy (Recruiting)
    • Roberta Caputo
  • Ospedale Maggiore della Carità, Novara, Italy (Recruiting)
    • Alessandra Gennari
  • IOV Istituto Oncologico Veneto IRCCS, Padova, Italy (Recruiting)
    • Maria Vittoria Dieci
  • Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (Recruiting)
    • Gianpiero Rizzo
  • IRCCS - ICS Maugeri, Pavia, Italy (Recruiting)
    • Barbara Tagliaferri
  • Clinica Ospedaliero - Universitaria Policlinico Umberto I, Roma, Italy (Recruiting)
    • Andrea Botticelli
  • Policlinico Universitario Campus Bio-Medico, Roma, Italy (Recruiting)
    • Francesco Pantano
  • Policlinico Universitario Fondazione Agostino Gemelli, Roma, Italy (Recruiting)
    • Alessandra Fabi
  • Istituto Clinico Humanitas, Rozzano, Italy (Recruiting)
    • Alberto Zambelli