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

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

HR+/HER2- Advanced Breast Cancer, HR+/HER2- Metastatic Breast Cancer, Palbociclib, Ribociclib, Abemaciclib, CDK4/6i, Cyclin-Dependent Kinase 4/6 inhibitors, Metastatic Breast Cancer

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.

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.

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