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Search / Trial 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

Launched by FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI, MILANO · Jan 28, 2025

Trial Information

Current as of July 24, 2025

Recruiting

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

ClinConnect Summary

The PALMARES-2 study is looking at how well certain treatments work for patients with advanced hormone receptor-positive, HER2-negative breast cancer. Specifically, it focuses on patients who are receiving a combination of CDK4/6 inhibitors (like palbociclib, ribociclib, or abemaciclib) along with endocrine therapy as their first line of treatment. The goal of the study is to gather real-world data from various sources, including medical images and biological samples, to understand how these treatments can help patients.

To be eligible for the study, participants need to have been diagnosed with advanced breast cancer that is hormone receptor-positive and HER2-negative. This means their cancer cells have certain receptors that can be targeted by specific treatments. Participants must also be starting treatment with one of the mentioned CDK4/6 inhibitors in combination with endocrine therapy. Throughout the study, participants will be monitored to evaluate their treatment outcomes and any side effects. It's important to know that this study aims to provide insights that can help improve treatment strategies for patients with this type of breast cancer.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.

About Fondazione Irccs Istituto Nazionale Dei Tumori, Milano

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano is a leading cancer research and treatment institution in Italy, dedicated to advancing the understanding and management of oncological diseases. As a prominent clinical trial sponsor, the foundation focuses on innovative research aimed at developing new therapeutic strategies and improving patient outcomes. With a commitment to translational medicine, it collaborates with a network of national and international partners to facilitate cutting-edge clinical trials, enhance cancer care, and contribute to the global body of oncological knowledge.

Locations

Rozzano, , Italy

Genova, , Italy

Novara, , Italy

Pavia, Pv, Italy

Firenze, , Italy

Roma, , Italy

Milano, , Italy

Milano, , Italy

Napoli, , Italy

Como, , Italy

Meldola, , Italy

Roma, , Italy

Catania, , Italy

Aviano, , Italy

Brescia, , Italy

Cremona, , Italy

Milano, , Italy

Milano, , Italy

Mirano, , Italy

Modena, , Italy

Napoli, , Italy

Padova, , Italy

Pavia, , Italy

Roma, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported