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NCT06805812Recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
3500 (estimated)
First submitted
7 Jan 2025
Start date
1 May 2023
Primary completion date
31 Dec 2030
Lead sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
NCT number
NCT06805812

What you commit to

  • Study type: Observational
  • Planned participants: 3500
  • From 1 May 2023 to the primary completion date, 31 Dec 2030
  • 24 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have received CDK4/6i as monotherapy;
  • Have received CDK4/6i as adjuvant treatment for localized disease.

Other

  • Less than 3 months of follow up from the CDK4/6i start to the date of data cut-off;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro di Riferimento Oncologico IRCCS
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AvianoItalyRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili
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BresciaItalyRecruiting
Humanitas Istituto Clinico Catanese
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CataniaItalyRecruiting
ASST Lariana - Ospedale Sant'Anna
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ComoItalyRecruiting
ASST Ospedale Maggiore
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CremonaItalyRecruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyRecruiting
Ospedale San Martino
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GenovaItalyRecruiting
Istituto Tumori della Romagna IRST IRCCS
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MeldolaItalyRecruiting
Ospedale ASST Fatebenefratelli Sacco
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MilanItalyRecruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore
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MilanItalyRecruiting
IEO Istituto Europeo di Oncologia
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MilanItalyRecruiting
IRCCS Ospedale San Raffaele
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MilanItalyRecruiting
ULSS 3 Veneto
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MiranoItalyRecruiting
Azienda Ospedaliero-Universitaria
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ModenaItalyRecruiting
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
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NaplesItalyRecruiting
Azienda Ospedaliero-Universitaria Federico II
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NaplesItalyRecruiting
Ospedale Maggiore della Carità
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NovaraItalyRecruiting
IOV - Istituto Oncologico Veneto IRCCS
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PadovaItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyRecruiting
IRCCS - ICS Maugeri
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PaviaItalyRecruiting
Policlinico Universitario Fondazione Agostino Gemelli
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RomaItalyRecruiting
Policlinico Universitario Campus Bio-Medico
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RomaItalyRecruiting
Clinica Ospedaliero - Universitaria Policlinico Umberto I
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RomaItalyRecruiting
Istituto Clinico Humanitas
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RozzanoItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.