RecruitingNot Applicable

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

Italy3,500 participantsStarted 2023-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Overall Survival (OS)

Timeframe: From the first-line treatment start to date of any-cause death or last follow up, up to 120 months

Trial details

NCT IDNCT06805812

SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-12-31

Contact for this trial

Claudio Vernieri, M.D., Ph.D.

+390223903066 claudio.vernieri@istitutotumori.mi.it