NCT07180693

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 750 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will also evaluate clinico-pathologic characteristics, patterns of recurrence, therapeutic choices and outcomes of the subgroup of patients relapsed during or within 12 months after adjuvant therapy with CDK4/6 inhibitors in combination with ET.

Conditions

• Adjuvant Therapy
• CDK4/6 Inhibitor

Timeline

• Start date: 2025-09-29
• Primary completion: 2028-08-01
• Completion: 2030-08-01
• First posted: 2025-09-18
• Last updated: 2026-04-01

Locations

18 sites across 1 country: Italy