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

Keywords

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.