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

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

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

Sponsors & Collaborators

• European Institute of Oncology, Italy

  collaborator UNKNOWN

• Humanitas Research Hospital IRCCS, Rozzano-Milan

  collaborator OTHER

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

  collaborator OTHER

• OSPEDALE ASST CREMONA

  collaborator UNKNOWN

• IOV Oncologico Veneto Padova

  collaborator UNKNOWN

• ASST Fatebenefratelli Sacco

  collaborator OTHER

• IRCCS Fondazione Salvatore Maugeri, Pavia, Italy

  collaborator UNKNOWN

• IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola

  collaborator UNKNOWN

• Azienda Ospedaliero-Universitaria di Modena

  collaborator OTHER

• Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

  collaborator UNKNOWN

• A.O.U. Federico II, Napoli

  collaborator UNKNOWN

• San Raffaele University Hospital, Italy

  collaborator OTHER

• Centro di Riferimento Oncologico - Aviano

  collaborator OTHER

• Azienda Socio-Sanitaria Territoriale Lariana

  collaborator UNKNOWN

• Azienda ULSS 3 Serenissima, Ospedale di Mirano

  collaborator UNKNOWN

• Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma

  collaborator UNKNOWN

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

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

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Azienda Ospedaliero-Universitaria Careggi

  collaborator OTHER

• Humanitas, Istituto Clinico Catanese

  collaborator OTHER_GOV

• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

  collaborator NETWORK

• Fondazione Policlinico Universitario Campus Bio-Medico

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-01

Primary Completion

2030-12-31

Completion

2040-12-31

FDA Drug

Yes

Countries

• Italy

Study Locations