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

NCT07539753 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Jiangmen Central Hospital

    collaborator OTHER

  • Dongguan People's Hospital

    collaborator OTHER_GOV

  • Sun Yat-Sen University Cancer Center

    collaborator OTHER

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Meizhou People's Hospital

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-08-01
Completion
2029-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07539753 on ClinicalTrials.gov