NCT06805812 - 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 | Biotech Hunter

Enrollment

3,500

Participants

Timeline

Start Date

May 1, 2023

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2040

Conditions

Breast AdenocarcinomaBreast Cancer Stage IVBreast Cancer, MetastaticBreast CarcinomaBreast DiseasesBreast NeoplasmsBreast Neoplasms, MaleBreast CancerBreast Cancer With Metastatic Bone DiseaseBreast CancersBreast NeoplasmBreast TumorsHR+ HER2- Men, Pre/Postmenopausal Advanced Breast CancerHR+ Advanced or Metastatic Breast CancerHR+/HER2- Breast CancerHRpos Breast NeoplasmsHR-positive, HER2-negative Advanced Breast CancerHR-positive, HER2-negative and PIK3CA Mutation Advanced Breast CancerHR-positive Breast CancerHormone Receptor-Positive Breast CancerHormone Receptor Positive Breast AdenocarcinomaHormone Receptor Positive Breast CarcinomaHormone Receptor Positive Breast NeoplasmsHormone Receptor Positive HER-2 Negative Breast CancerHormone Receptor Positive Malignant Neoplasm of BreastHormone Receptor Positive Metastatic Breast CancerHormone Receptor Positive, HER2 Negative Breast CancerHormone Receptor Negative Breast CancerHormone Receptor Positive, HER2-negative, Advanced Breast CancerHormone Receptor Positive Breast CancerHormone Receptor Positive (ER+/PR+, and Her2-) Metastatic Breast CancerHormone Receptor Positive, HER2-negative NeoplasmsHormone Receptor Positive, HER2-low NeoplasmsHormone Receptor Positive (HR+), HER2-negative Breast CancerHormone Receptor (HR)-Positive Breast CancerHormone Receptor-Positive, HER2-Negative Metastatic Breast CancerPalbociclibRibociclibAbemaciclibCDK4/6 InhibitorCDK4/6 Inhibitors

Interventions

DRUG

Palbociclib

Administered in combination with endocrine therapy

DRUG

Ribociclib

Administered in combination with endocrine therapy

DRUG

Abemaciclib

Administered in combination with endocrine therapy

Trial Locations (24)

Unknown

RECRUITING

Centro di Riferimento Oncologico IRCCS, Aviano

RECRUITING

Azienda Socio Sanitaria Territoriale degli Spedali Civili, Brescia

RECRUITING

Humanitas Istituto Clinico Catanese, Catania

RECRUITING

ASST Lariana - Ospedale Sant'Anna, Como

RECRUITING

ASST Ospedale Maggiore, Cremona

RECRUITING

Azienda Ospedaliero Universitaria Careggi, Florence

RECRUITING

Ospedale San Martino, Genova

RECRUITING

Istituto Tumori della Romagna IRST IRCCS, Meldola

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore, Milan

RECRUITING

IEO Istituto Europeo di Oncologia, Milan

RECRUITING

IRCCS Ospedale San Raffaele, Milan

RECRUITING

Ospedale ASST Fatebenefratelli Sacco, Milan

RECRUITING

ULSS 3 Veneto, Mirano

RECRUITING

Azienda Ospedaliero-Universitaria, Modena

RECRUITING

Azienda Ospedaliero-Universitaria Federico II, Napoli

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli

RECRUITING

Ospedale Maggiore della Carità, Novara

RECRUITING

IOV Istituto Oncologico Veneto IRCCS, Padua

RECRUITING

Fondazione IRCCS Policlinico San Matteo, Pavia

RECRUITING

IRCCS - ICS Maugeri, Pavia

RECRUITING

Clinica Ospedaliero - Universitaria Policlinico Umberto I, Roma

RECRUITING

Policlinico Universitario Campus Bio-Medico, Roma

RECRUITING

Policlinico Universitario Fondazione Agostino Gemelli, Roma

RECRUITING

Istituto Clinico Humanitas, Rozzano

All Listed Sponsors

collaborator

European Institute of Oncology, Italy

UNKNOWN

collaborator

Humanitas Research Hospital IRCCS, Rozzano-Milan

OTHER

collaborator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

collaborator

OSPEDALE ASST CREMONA

UNKNOWN

collaborator

IOV Oncologico Veneto Padova

UNKNOWN

collaborator

ASST Fatebenefratelli Sacco

OTHER

collaborator

IRCCS Fondazione Salvatore Maugeri, Pavia, Italy

UNKNOWN

collaborator

IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola

UNKNOWN

collaborator

Azienda Ospedaliero-Universitaria di Modena

OTHER

collaborator

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

UNKNOWN

collaborator

A.O.U. Federico II, Napoli

UNKNOWN

collaborator

San Raffaele University Hospital, Italy

OTHER

collaborator

Centro di Riferimento Oncologico - Aviano

OTHER

collaborator

Azienda Socio-Sanitaria Territoriale Lariana

UNKNOWN

collaborator

Azienda ULSS 3 Serenissima, Ospedale di Mirano

UNKNOWN

collaborator

Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma

UNKNOWN

collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

collaborator

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

OTHER

collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

collaborator

Azienda Ospedaliero-Universitaria Careggi

OTHER

collaborator

Humanitas, Istituto Clinico Catanese

OTHER_GOV

collaborator

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

NETWORK

collaborator

Fondazione Policlinico Universitario Campus Bio-Medico

OTHER

collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

lead

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER