NCT06805812

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,500 (estimated)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
DRUG	Palbociclib	Administered in combination with endocrine therapy
DRUG	Ribociclib	Administered in combination with endocrine therapy
DRUG	Abemaciclib	Administered in combination with endocrine therapy

Timeline

• Start date: 2023-05-01
• Primary completion: 2030-12-31
• Completion: 2040-12-31
• First posted: 2025-02-03
• Last updated: 2025-02-03

Locations

24 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study