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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status: Enrolling

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

Treatments: Drug: Palbociclib; Drug: Abemaciclib; Drug: Ribociclib

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT06805812

INT101/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design