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Recruiting 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

Trial Parameters

Condition Breast Adenocarcinoma
Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Type OBSERVATIONAL
Phase N/A
Enrollment 3,500
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-05-01
Completion 2030-12-31
All 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
PalbociclibRibociclibAbemaciclib

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.

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.

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