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Breast AdenocarcinomaPALMARES-2NCT06805812

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

An observational study of Breast Adenocarcinoma and Breast Cancer Stage IV, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 24 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Palbociclib, Ribociclib and Abemaciclib
How many people
3,500 participants
Where
24 sitesItaly
Study dates
1 May 2023to 31 Dec 2040
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study involves the retrospective and prospective collection of consecutive HR+/HER2- advanced Breast Cancer patients (defined as metastatic or locally advanced not candidate for definitive curative intervention) treated with CDK4/6i in combination with endocrine therapy as first-line treatment for advanced disease in different Italian cancer centers.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

+390223903066

claudio.vernieri@istitutotumori.mi.it

24 sites in 1 country

Italy24 sites, 24 recruiting

  • Centro di Riferimento Oncologico IRCCS

    Aviano

    Lorenzo Gerratana, +390434659111, elena.nascimbeni@cro.it

    Recruiting

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili

    Brescia

    Rebecca Pedersini, +3903039951, giadamola.gm@gmail.com

    Recruiting

  • Humanitas Istituto Clinico Catanese

    Catania

    Paolo Vigneri, +390957339000, domenica.caponnetto@humanitascatania.it

    Recruiting

  • ASST Lariana - Ospedale Sant'Anna

    Como

    Monica Giordano, +390315855602, gilardonimicol@libero.it

    Recruiting

  • ASST Ospedale Maggiore

    Cremona

    Daniele Generali, +390372405246, valeria.cervoni@asst-cremona.it

    Recruiting

  • Azienda Ospedaliero Universitaria Careggi

    Florence

    Icro Meattini, +390557947908, carracinom@aou-careggi.toscana.it

    Recruiting

  • Ospedale San Martino

    Genova

    Matteo Lambertini, +390105558912

    Recruiting

  • Istituto Tumori della Romagna IRST IRCCS

    Meldola

    Marianna Sirico, +390543739100, emanuela.montanari@irst.emr.it

    Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore

    Milan

    Ornella Garrone, +390255032783, eleonora.galbiati@policlinico.mi.it

    Recruiting

  • IEO Istituto Europeo di Oncologia

    Milan

    Giuseppe Curigliano, +3902574891, datamanagement@ieo.it

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan

    Marta Piras, +390226437627, ctc.trialstartup@hsr.it

    Recruiting

  • Ospedale ASST Fatebenefratelli Sacco

    Milan

    Nicla La Verde, +390239041, onco.datamanager@asst-fbf-sacco.it

    Recruiting

  • ULSS 3 Veneto

    Mirano

    Donata Sartori, +390415133483, silvia.coccato@aulss3.veneto.it

    Recruiting

  • Azienda Ospedaliero-Universitaria

    Modena

    Angela Toss, +390594222230, martina.manni@unimore.it

    Recruiting

  • Azienda Ospedaliero-Universitaria Federico II

    Naples

    Mario Giuliano, +390817463660, studiclinici.oncologia@unina.it

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples

    Roberta Caputo, +3908117770133, c.ferrara@istitutotumori.na.it

    Recruiting

  • Ospedale Maggiore della Carità

    Novara

    Alessandra Gennari, +3903213733820, trialsonconovara@gmail.com

    Recruiting

  • IOV Istituto Oncologico Veneto IRCCS

    Padova

    Maria Vittoria Dieci, +390498211111, oncologia2@iov.veneto.it

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia

    Gianpiero Rizzo, +390382502114, alessandra.ferrari@smatteo.pv

    Recruiting

  • IRCCS - ICS Maugeri

    Pavia

    Barbara Tagliaferri, +3903825921, annalisa.lanza@icsmaugeri.it

    Recruiting

  • Clinica Ospedaliero - Universitaria Policlinico Umberto I

    Roma

    Andrea Botticelli, +390649971, alessandra.gargiulo@uniroma1.it

    Recruiting

  • Policlinico Universitario Campus Bio-Medico

    Roma

    Francesco Pantano, +3906225411, comitato.etico@policlinicocampus.it

    Recruiting

  • Policlinico Universitario Fondazione Agostino Gemelli

    Roma

    Alessandra Fabi, +390630154844, lucamaria.tamponi@guest.policlinicogemelli.it

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano

    Alberto Zambelli, +390282244330, info@humanitas.it

    Recruiting

Other trials in Italy

About this study

Official title: 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

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.

Read the detailed description

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.
Being tested
Palbociclib, Ribociclib, Abemaciclib
Keywords
HR+/HER2- Advanced Breast Cancer, HR+/HER2- Metastatic Breast Cancer, Palbociclib, Ribociclib, Abemaciclib, CDK4/6i, Cyclin-Dependent Kinase 4/6 inhibitors, Metastatic Breast Cancer
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis, Breast Diseases, Breast Neoplasms, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalbociclibDrug

    Administered in combination with endocrine therapy

  • RibociclibDrug

    Administered in combination with endocrine therapy

  • AbemaciclibDrug

    Administered in combination with endocrine therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

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

Secondary outcomes (3)

  1. Real-world Progression-Free Survival (rwPFS)

    Measured: From the start of first-line treatment to date of disease progression documented in patient medical charts or death or last follow up, whichever occurs first, up to 120 months

  2. Time To Next Treatment or Death (TTNT-D)

    Measured: From the start of first-line treatment to date of subsequent therapy start or death or last follow up, whichever occurs first, up to 120 months

  3. Time To Chemotherapy or Death (TTC-D)

    Measured: From the start of first-line treatment to date of first chemotherapy for advanced disease start or death or last follow up, whichever occurs first, up to 120 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2025
  2. Study start1 May 2023
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
3,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06805812
Sponsor's protocol ID
INT101/23
Acronym
PALMARES-2
Status last verified
Dec 2024
First submitted
7 Jan 2025
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: IPD will be evaluated for submission

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