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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

Recruitingn/aAges 18 Years - anyAllFondazione IRCCS Istituto Nazionale dei Tumori, M…
NCT06805812 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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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What it tests

  • Palbociclib
  • Ribociclib
  • Abemaciclib
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Where

24 sites
Centro di Riferimento Oncologico IRCCS
Aviano, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili
Brescia, Italy
Humanitas Istituto Clinico Catanese
Catania, Italy
ASST Lariana - Ospedale Sant'Anna
Como, Italy
ASST Ospedale Maggiore
Cremona, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Ospedale San Martino
Genova, Italy
Istituto Tumori della Romagna IRST IRCCS
Meldola, Italy

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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