Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases

This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain metastases. Eligible patients present with newly diagnosed brain metastases or brain metastases that progressed following prior local therapy. It is hoped that this therapeutic combination can achieve disease control in these patients.

NCT Number	NCT07745257
Lead Sponsor	Sun Yat-sen University
Conditions	HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases
Enrollment	40 participants
Start Date	2026-08-28
Primary Completion	2027-12-28 (estimated)
Study Completion	2028-07-28 (estimated)
Updated on ClinicalTrials.gov	2026-08-04