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 (PALMARES-2)

January 28, 2025 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Aviano, Italy
        • Recruiting
        • Centro di Riferimento Oncologico IRCCS
        • Contact:
      • Brescia, Italy
        • Recruiting
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili
        • Contact:
      • Catania, Italy
      • Como, Italy
        • Recruiting
        • ASST Lariana - Ospedale Sant'Anna
        • Contact:
      • Cremona, Italy
      • Firenze, Italy
      • Genova, Italy
        • Recruiting
        • Ospedale San Martino
        • Contact:
          • Matteo Lambertini
          • Phone Number: +390105558912
      • Meldola, Italy
      • Milano, Italy
        • Recruiting
        • IEO Istituto Europeo di Oncologia
        • Contact:
      • Milano, Italy
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
      • Milano, Italy
      • Milano, Italy
      • Mirano, Italy
      • Modena, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria
        • Contact:
      • Napoli, Italy
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
        • Contact:
      • Napoli, Italy
      • Novara, Italy
        • Recruiting
        • Ospedale Maggiore della Carità
        • Contact:
      • Padova, Italy
        • Recruiting
        • IOV Istituto Oncologico Veneto IRCCS
        • Contact:
      • Pavia, Italy
      • Pavia, Italy
      • Roma, Italy
      • Roma, Italy
      • Roma, Italy
        • Recruiting
        • Clinica Ospedaliero - Universitaria Policlinico Umberto I
        • Contact:
      • Rozzano, Italy
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From the first-line treatment start to date of any-cause death or last follow up, up to 120 months
From the first-line treatment start to date of any-cause death or last follow up, up to 120 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Real-world Progression-Free Survival (rwPFS)
Time Frame: 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
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
Time To Next Treatment or Death (TTNT-D)
Time Frame: 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
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
Time To Chemotherapy or Death (TTC-D)
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Centro di Riferimento Oncologico - Aviano
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
ASST Fatebenefratelli Sacco
Azienda Ospedaliero-Universitaria di Modena
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Azienda Ospedaliero-Universitaria Careggi
San Raffaele University Hospital, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Humanitas Research Hospital IRCCS, Rozzano-Milan
Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma
Azienda Socio-Sanitaria Territoriale Lariana
IRCCS Fondazione Salvatore Maugeri, Pavia, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Azienda ULSS 3 Serenissima, Ospedale di Mirano
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola
European Institute of Oncology, Italy
OSPEDALE ASST CREMONA
IOV Oncologico Veneto Padova
A.O.U. Federico II, Napoli
Humanitas, Istituto Clinico Catanese

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2040

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT101/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will be evaluated for submission

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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