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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Palbociclib
  • Ribociclib
  • Abemaciclib

Treatment groups

No treatment groups listed

Sponsors and collaborators

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead sponsor

European Institute of Oncology, Italy

Collaborator

Humanitas Research Hospital IRCCS, Rozzano-Milan

Collaborator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Collaborator

OSPEDALE ASST CREMONA

Collaborator

IOV Oncologico Veneto Padova

Collaborator

ASST Fatebenefratelli Sacco

Collaborator

IRCCS Fondazione Salvatore Maugeri, Pavia, Italy

Collaborator

IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola

Collaborator

Azienda Ospedaliero-Universitaria di Modena

Collaborator

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Collaborator

A.O.U. Federico II, Napoli

Collaborator

San Raffaele University Hospital, Italy

Collaborator

Centro di Riferimento Oncologico - Aviano

Collaborator

Azienda Socio-Sanitaria Territoriale Lariana

Collaborator

Azienda ULSS 3 Serenissima, Ospedale di Mirano

Collaborator

Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma

Collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

Collaborator

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborator

Azienda Ospedaliero-Universitaria Careggi

Collaborator

Humanitas, Istituto Clinico Catanese

Collaborator

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Collaborator

Fondazione Policlinico Universitario Campus Bio-Medico

Collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborator