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Predicting clinicAL outcoMes ...

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

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2040-12-31

Brief Summary

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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.

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Detailed Description

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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

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Palbociclib

Administered in combination with endocrine therapy

Intervention Type DRUG

Ribociclib

Administered in combination with endocrine therapy

Intervention Type DRUG

Abemaciclib

Administered in combination with endocrine therapy

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers