# 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 · sponsor: **Fondazione IRCCS Istituto Nazionale dei Tumori, Milano** · enrollment: 3500 (estimated)

## Conditions studied

- 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 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 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

## Interventions

- **DRUG:** Palbociclib
- **DRUG:** Ribociclib
- **DRUG:** Abemaciclib

## Key facts

- **NCT ID:** NCT06805812
- **Lead sponsor:** Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- **Sponsor class:** OTHER
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** RECRUITING
- **Start date:** 2023-05-01
- **Primary completion:** 2030-12-31
- **Final completion:** 2040-12-31
- **Target enrollment:** 3500 (ESTIMATED)
- **Last updated:** 2025-02-03

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06805812

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-06-16 from https://api.ai-analytics.org/clinical/NCT06805812. Licensed CC0.

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