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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported