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

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study ID
NCT06805812
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
May 1, 2023
Status verified
Dec 2024
Primary completion
Dec 31, 2030
Completion
Dec 31, 2040

Study Design

Enrollment
3,500 participants (estimated)

Primary Outcome Measure

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 ]

Central Contacts

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