RecruitingNCT07180693

Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:

Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: Evaluation in the Real-world Setting

Sponsor

European Institute of Oncology

Enrollment

750 participants

Start Date

Sep 29, 2025

Study Type

OBSERVATIONAL

Conditions

Adjuvant Therapy CDK4/6 Inhibitor

Summary

This is a multicenter observational study with both retrospective and prospective phase, designed to evaluate the clinico-pathologic characteristics and outcomes of patients with HR+/HER2- EBC at high risk of recurrence treated with ribociclib or abemaciclib in combination with ET in the adjuvant setting.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is following patients with hormone receptor-positive, HER2-negative early breast cancer who relapse while on or after CDK4/6 inhibitor therapy (like abemaciclib or ribociclib). It aims to understand patterns of recurrence and outcomes in this specific group. **You may be eligible if...** - You are 18 or older (male or female) - You have hormone receptor-positive, HER2-negative breast cancer that was surgically removed - You started treatment with a CDK4/6 inhibitor combined with hormone therapy on or after January 1, 2021 - Your cancer has since relapsed or spread **You may NOT be eligible if...** - Your breast cancer is HER2-positive or hormone receptor-negative - You have not received a CDK4/6 inhibitor as part of your treatment - You are currently pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(18)

ASST Papa Giovanni XXIII

Bergamo, Italy, Italy

ASST Spedali Civili di Brescia

Brescia, Italy, Italy

P.O. Antonio Perrino - ASL Brindisi

Brindisi, Italy, Italy

ASST Ospedale Maggiore di Crema

Crema, Italy, Italy

ASST Lecco - PO Alessandro Manzoni

Lecco, Italy, Italy

Asst Ovest Milanese

Legnano, Italy, Italy

IRCCS Ospedale San Raffaele

Milan, Italy, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Italy, Italy

European Institute of Oncology

Milan, Italy, Italy

PO Luigi Sacco - ASST Fatebenefratelli Sacco

Milan, Italy, Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy, Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Italy, Italy

ICS Maugeri IRCCS

Pavia, Italy, Italy

Policlinico San Matteo

Pavia, Italy, Italy

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, Italy

Ospedale Isola Tiberina - Gemelli Isola

Roma, Italy, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07180693

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