Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative Advanced Breast Cancer With Brain Metastases

This is a prospective, open-label, exploratory clinical trial designed to evaluate the efficacy and safety of brain radiotherapy combined with dalpiciclib and endocrine therapy in HR-positive/HER2-negative advanced breast cancer patients with brain metastases. A total of 46 patients are planned to be enrolled. Participants will receive dalpiciclib plus endocrine therapy and brain radiotherapy, including fractionated stereotactic radiotherapy (FSRT) or whole-brain radiotherapy (WBRT), according to the clinical characteristics of brain metastatic lesions. Radiotherapy may start within 30 days before or after initiation of drug treatment. Dalpiciclib and endocrine therapy may be given concurrently during radiotherapy and will be continued after radiotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or investigator decision. Participants will visit the clinic once every 3 months for checkups and tests. Tumor response will be assessed according to RECIST version 1.1, and safety will be evaluated throughout the study.

NCT Number	NCT07539753
Lead Sponsor	Nanfang Hospital, Southern Medical University Collaborators: Jiangmen Central Hospital, Dongguan People's Hospital, Sun Yat-Sen University Cancer Center, Fifth Affiliated Hospital, Sun Yat-Sen University, Meizhou People's Hospital
Conditions	Breast Cancer, Brain Metastases, HR+/HER2- Breast Cancer
Enrollment	46 participants
Start Date	2026-06-01
Primary Completion	2029-08-01 (estimated)
Study Completion	2029-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-30