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Analysis of second-line treatments for advanced HR+/HER2- breast cancer after initial therapy failure

Multicenter Retrospective Observational (Descriptive) Study of Second-line Therapies After Progression to CDK4/6i in Association With Hormone Therapy, in Patients With HR+/HER2- Advanced Breast Cancer (HERMIONE 13)

Observational University of Milano Bicocca · NCT05173103

This study looks at the different second-line treatments for patients with advanced breast cancer that is hormone receptor-positive and HER2-negative, who didn't respond to their first treatment, to see what options worked best for them.

Quick facts

Study typeObservational
Enrollment150 (estimated)
Ages18 Years and up
SexFemale
SponsorUniversity of Milano Bicocca Academic / other
Drugs / interventionschemotherapy
Locations29 sites (Ancona and 28 other locations)
Trial IDNCT05173103 on ClinicalTrials.gov

What this trial studies

This multicenter retrospective observational study examines the choices made for second-line treatments in patients with hormone receptor-positive, HER2-negative advanced breast cancer who have progressed after initial treatment with CDK4/6 inhibitors and hormonal therapy. The study will collect data from 150 patients treated between January 2016 and December 2020, focusing on their characteristics, treatment history, and outcomes. The aim is to provide insights into real-world treatment patterns and effectiveness in this patient population.

Who should consider this trial

Good fit: Ideal candidates are women over 18 years old with hormone receptor-positive, HER2-negative advanced breast cancer who have experienced progression after first-line treatment.

Not a fit: Patients with previous chemotherapy treatments for advanced disease or those under 18 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify effective second-line treatment options for patients with advanced HR+/HER2- breast cancer.

How similar studies have performed: While similar studies have explored treatment patterns in advanced breast cancer, this specific analysis of second-line therapies after CDK4/6 inhibitors is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* age\> 18 years
* female sex
* Performance Status (ECOG) 0-2;
* hormonal-receptor positive breast cancer (Estrogen and / or Progesterone positive), HER2 negative, with evidence of stage IV / locally advanced inoperable disease
* Radiologically documented progression in 1st line treatment with Hormonal Therapy (Aromatase inhibitor / Fulvestrant) + CDK4-6i (Palbociclib / Ribociclib / Abemaciclib)
* Execution of at least one subsequent therapeutic line chosen by the clinician, with at least one radiological re-evaluation during this treatment by 31 December 2020.
* Radiologically measurable or evaluable lesions
* Written informed consent

Exclusion Criteria:

* age \<18 years
* previous neoplastic pathology, within 5 years of the last active treatment
* Previous chemotherapy treatments, with biological or endocrine therapies for advanced disease, different from first-line therapy with OT + CDK4 / 6i

Where this trial is running

Ancona and 28 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 Advanced Breast CancerHormone Receptor Positive Breast CarcinomaHER2-negative Breast Canceradvanced breast cancerhormonal therapyCDK 4/6 inhibitors
Last reviewed 2026-06-10 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.