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ClinicalTrials.gov ID

NCT06805812

Lead Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

3,500Estimated

Last Update Posted

Feb 3, 2025Actual

Start Date

May 1, 2023Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2040Estimated

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.

Detailed Description

The PALMARES-2 study aims to collect data from different sources, i.e. real-world clinical data, medical images and biological data and samples, from patients treated with CDK4/6i as first-line therapy for patients with HR+/HER2- advanced breast cancer. Due to the complexity of the data collected and the different objectives of the study, this protocol includes several sub-studies, which include different methodologies for data collection, extraction and analysis:

• The first sub-study (RWD sub-study) will aim to collect real-world clinical data of patients who received ET+CDK4/6i in the first-line setting; the primary objective of this sub-study is to assess whether there is a difference in OS between the three CDK4/6i in the real-world population, while secondary objectives include comparisons in specific sub-groups;
• The second sub-study (Safety sub-study) includes the collection of comorbidities, concomitant medications and toxicities of patients enrolled in the study; the primary objective of this sub-study is to evaluate the difference in severe toxicity between the three CDK4/6i in the real-world population
• The third sub-study (medical imaging sub-study) consists of the collection of computed tomography (CT) and fluorodeoxyglucose positron emission tomography (FdG-PET) images at baseline and digitised haematoxylin-eosin (HE) slides to build a multi-omics predictive model;
• The fourth sub-study (translational sub-study) aims to collect tumour samples from a proportion of patients enrolled in the study to perform genomics and transcriptomics analyses; information from this data source will be integrated into the model built with the previous data to further improve the performance of the previous model
• The fifth sub-study (subsequent lines sub-study) focuses on the lines of treatment administered to patients enrolled in the study at the time of progression after first-line treatment with ET+CDK4/6i, with the aim of building predictive models of response to subsequent lines of treatment, capable of supporting oncologists' and patients' decisions in this context.

• 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

• Palbociclib
• Ribociclib
• Abemaciclib

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Other

Lead Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoOTHER

Collaborators

European Institute of Oncology, ItalyUNKNOWN

Humanitas Research Hospital IRCCS, Rozzano-MilanOTHER

Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaOTHER

OSPEDALE ASST CREMONAUNKNOWN

IOV Oncologico Veneto PadovaUNKNOWN

ASST Fatebenefratelli SaccoOTHER

IRCCS Fondazione Salvatore Maugeri, Pavia, ItalyUNKNOWN

IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori MeldolaUNKNOWN

Azienda Ospedaliero-Universitaria di ModenaOTHER

Azienda Ospedaliero Universitaria Maggiore della CaritaOTHER

A.O.U. Federico II, NapoliUNKNOWN

San Raffaele University Hospital, ItalyOTHER

Centro di Riferimento Oncologico - AvianoOTHER

Azienda Socio-Sanitaria Territoriale LarianaUNKNOWN

Azienda ULSS 3 Serenissima, Ospedale di MiranoUNKNOWN

Azienda Ospedaliero Universitaria Policlinico Umberto I, RomaUNKNOWN

Fondazione IRCCS Policlinico San Matteo di PaviaOTHER

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Azienda Ospedaliero-Universitaria CareggiOTHER

Humanitas, Istituto Clinico CataneseOTHER_GOV

Istituto Nazionale Tumori IRCCS - Fondazione G. PascaleNETWORK

Fondazione Policlinico Universitario Campus Bio-MedicoOTHER

Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoOTHER

silvia.coccato@aulss3.veneto.it+390415133483