Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07539753
PHASE2

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

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: A Single-Arm, Phase II Study of Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative Advanced Breast Cancer Patients With Brain Metastases

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2026-06-01

Completion Date

2029-08-01

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

DRUG

Dalpiciclib

Dalpiciclib will be administered orally at 125 mg once daily for 21 days followed by 7 days off in a 28-day cycle.

DRUG

Endocrine Therapy of Physician's Choice

Endocrine therapy will be selected by the treating physician according to clinical practice.

RADIATION

Brain Radiotherapy

Brain radiotherapy will include fractionated stereotactic radiotherapy (FSRT) or whole-brain radiotherapy (WBRT), according to the number, size, location, and distribution of brain metastatic lesions.

Locations (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China