Predicting outcomes for advanced breast cancer patients treated with CDK4/6 inhibitors and endocrine therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PALMARES-2 study is a multicenter, observational study that aims to gather real-world evidence on patients with HR+/HER2- advanced breast cancer receiving first-line treatment with CDK4/6 inhibitors combined with endocrine therapy. It will collect data from various sources, including clinical records, medical imaging, and biological samples, to assess overall survival and safety outcomes among different CDK4/6 inhibitors. The study includes multiple sub-studies focusing on real-world data, safety, medical imaging, and translational research to build predictive models. This comprehensive approach aims to enhance understanding of treatment effectiveness and patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centro di Riferimento Oncologico IRCCS
  Aviano, Italy Recruiting
• Azienda Socio Sanitaria Territoriale degli Spedali Civili
  Brescia, Italy Recruiting
• Humanitas Istituto Clinico Catanese
  Catania, Italy Recruiting
• ASST Lariana - Ospedale Sant'Anna
  Como, Italy Recruiting
• ASST Ospedale Maggiore
  Cremona, Italy Recruiting
• Azienda Ospedaliero Universitaria Careggi
  Florence, Italy Recruiting

Study contacts

• Study coordinator: Claudio Vernieri, M.D., Ph.D.
• Email: claudio.vernieri@istitutotumori.mi.it
• Phone: +390223903066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.