deltatrials
Recruiting OBSERVATIONAL 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 (PALMARES-2)

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

Sponsor: A.O.U. Federico II, Napoli

Conditions Abemaciclib Breast Adenocarcinoma Breast Cancer Breast Cancer Stage IV Breast Cancer With Metastatic Bone Disease Breast Cancer, Metastatic Breast Cancers Breast Carcinoma Breast Diseases Breast Neoplasm Breast Neoplasms Breast Neoplasms, Male Breast Tumors CDK4/6 Inhibitor CDK4/6 Inhibitors HR+ Advanced or Metastatic Breast Cancer HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer HR+/HER2- Breast Cancer HR-positive Breast Cancer HR-positive, HER2-negative Advanced Breast Cancer HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer HRpos Breast Neoplasms Hormone Receptor (HR)-Positive Breast Cancer Hormone Receptor Negative Breast Cancer Hormone Receptor Positive (ER+/PR+, and Her2-) Metastatic Breast Cancer Hormone Receptor Positive (HR+), HER2-negative Breast Cancer Hormone Receptor Positive Breast Adenocarcinoma Hormone Receptor Positive Breast Cancer Hormone Receptor Positive Breast Carcinoma Hormone Receptor Positive Breast Neoplasms Hormone Receptor Positive HER-2 Negative Breast Cancer Hormone Receptor Positive Malignant Neoplasm of Breast Hormone Receptor Positive Metastatic Breast Cancer Hormone Receptor Positive, HER2 Negative Breast Cancer Hormone Receptor Positive, HER2-low Neoplasms Hormone Receptor Positive, HER2-negative Neoplasms Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Hormone Receptor-Positive Breast Cancer Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Palbociclib Ribociclib
Interventions Abemaciclib Palbociclib Ribociclib
Updated 2 times since 2025 Last updated: Jan 28, 2025 Started: May 1, 2023 Primary completion: Dec 31, 2030 Completion: Dec 31, 2040
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Abemaciclib and Breast Adenocarcinoma and is currently actively recruiting participants. A.O.U. Federico II, Napoli leads this study, which shows 2 recorded versions since 2023 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Mar 2025 – ~Sep 2025 · 6 months · monthly snapshotRecruiting~Sep 2025 – present · 9 months · monthly snapshotRecruiting

Change History

2 versions recorded

  1. Sep 2025 — Present [monthly]

    Recruiting

  2. Mar 2025 — Sep 2025 [monthly]

    Recruiting

    First recorded

May 2023

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

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

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aviano, Italy , Brescia, Italy , Catania, Italy , Como, Italy , Cremona, Italy , Florence, Italy , Genova, Italy , Meldola, Italy , Milan, Italy , Mirano, Italy and 7 more locations