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

NCT06805812 | Recruiting FDA Drug

• 1 other identifier: INT101/23
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Breast Adenocarcinoma; Breast Cancer Stage IV; Breast Cancer, Metastatic; Breast Carcinoma; Breast Diseases; Breast Neoplasms; Breast Neoplasms, Male; Breast Cancer; Breast Cancer With Metastatic Bone Disease; Breast Cancers; Breast Neoplasm; Breast Tumors; HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer; HR+ Advanced or Metastatic Breast Cancer; HR+/HER2- Breast Cancer; HRpos Breast Neoplasms; HR-positive, HER2-negative Advanced Breast Cancer; HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer; HR-positive Breast Cancer; Hormone Receptor-Positive Breast Cancer; Hormone Receptor Positive Breast Adenocarcinoma; Hormone Receptor Positive Breast Carcinoma; Hormone Receptor Positive Breast Neoplasms; Hormone Receptor Positive, HER2 Negative Breast Cancer; Hormone Receptor Positive Malignant Neoplasm of Breast; Hormone Receptor Positive Metastatic Breast Cancer; Hormone Receptor Negative Breast Cancer; Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer; Hormone Receptor Positive Breast Cancer; Hormone Receptor Positive (ER+/PR+, and Her2-) Metastatic Breast Cancer; Hormone Receptor Positive, HER2-negative Neoplasms; Hormone Receptor Positive, HER2-low Neoplasms; Hormone Receptor Positive (HR+), HER2-negative Breast Cancer; Hormone Receptor (HR)-Positive Breast Cancer; Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer; Palbociclib; Ribociclib; Abemaciclib; CDK4/6 Inhibitor; CDK4/6 Inhibitors

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

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

Secondary Outcomes (3)

• Real-world Progression-Free Survival (rwPFS)

  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)

  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)

  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

Interventions

Palbociclib DRUG

Administered in combination with endocrine therapy

Ribociclib DRUG

Administered in combination with endocrine therapy

Abemaciclib DRUG

Administered in combination with endocrine therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (24)

Centro di Riferimento Oncologico IRCCS

Aviano, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale degli Spedali Civili

Brescia, Italy

RECRUITING

Humanitas Istituto Clinico Catanese

Catania, Italy

RECRUITING

ASST Lariana - Ospedale Sant'Anna

Como, Italy

RECRUITING

ASST Ospedale Maggiore

Cremona, Italy

RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

RECRUITING

Ospedale San Martino

Genova, Italy

RECRUITING

Istituto Tumori della Romagna IRST IRCCS

Meldola, Italy

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore

Milan, Italy

RECRUITING

IEO Istituto Europeo di Oncologia

Milan, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

Ospedale ASST Fatebenefratelli Sacco

Milan, Italy

RECRUITING

ULSS 3 Veneto

Mirano, Italy

RECRUITING

Azienda Ospedaliero-Universitaria

Modena, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Federico II

Napoli, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, Italy

RECRUITING

Ospedale Maggiore della Carità

Novara, Italy

RECRUITING

IOV Istituto Oncologico Veneto IRCCS

Padua, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

RECRUITING

IRCCS - ICS Maugeri

Pavia, Italy

RECRUITING

Clinica Ospedaliero - Universitaria Policlinico Umberto I

Roma, Italy

RECRUITING

Policlinico Universitario Campus Bio-Medico

Roma, Italy

RECRUITING

Policlinico Universitario Fondazione Agostino Gemelli

Roma, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Archival tumor FFPE block

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Breast Diseases; Breast Neoplasms, Male

Interventions

palbociclib; ribociclib; abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

+390223903066; claudio.vernieri@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: February 3, 2025
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2040
• Last Updated: February 3, 2025

Record last verified: 2024-12

Locations

IT (24)