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

Predictive Impact of Peripheral Blood Lymphocytes on 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

Observational Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · NCT06805812

This study is trying to see how well different CDK4/6 inhibitors combined with hormone therapy work for people with advanced breast cancer and how safe they are.

Quick facts

Study typeObservational
Enrollment3500 (estimated)
Ages18 Years and up
SexAll
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other
Locations24 sites (Aviano and 23 other locations)
Trial IDNCT06805812 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with HR+/HER2- advanced breast cancer who are receiving or are candidates for first-line treatment with CDK4/6 inhibitors.

Not a fit: Patients who have received CDK4/6 inhibitors as monotherapy or as adjuvant treatment for localized disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the most effective treatment options for patients with advanced hormone receptor-positive breast cancer.

How similar studies have performed: Other studies have shown success with similar approaches in evaluating treatment outcomes for advanced breast cancer, indicating that this methodology is both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Aviano and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast AdenocarcinomaBreast Cancer Stage IVBreast Cancer, MetastaticBreast CarcinomaBreast DiseasesBreast NeoplasmsBreast Neoplasms, MaleBreast Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.