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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Dalpiciclib will be administered orally at 125 mg once daily for 21 days followed by 7 days off in a 28-day cycle, in combination with endocrine therapy by physicians choice. 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. FSRT will generally be used for patients with ≤4 brain metastases and a maximum lesion diameter of ≤3 cm, or for lesions requiring precise irradiation because of deep location or proximity to critical functional areas. WBRT will generally be used for patients with \>4 brain metastases, lesions \>3 cm, or widely distributed brain metastases not suitable for FSRT.
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Central Nervous System Progression-Free Survival (CNS-PFS)
CNS-PFS is measured from the date of first study treatment to the date of intracranial disease progression or death, whichever occurs first.
Time frame: 12 months
Central Nervous System Objective Response Rate (CNS-ORR)
CNS-ORR is defined as the percentage of participants whose best overall intracranial response is complete response (CR) or partial response (PR) from the start of study treatment until disease progression (determined by RECIST version 1.1).
Time frame: 12 months
Progression-Free Survival (PFS)
Defined as the time from the date of first study treatment to the first documented radiographic disease progression or death from any cause, whichever occurs first. For participants who have not experienced disease progression or death by the data cutoff date, or who start other anti-tumor therapy before documented progression, PFS will be censored at the date of the last adequate tumor assessment before the cutoff date or before the initiation of other anti-tumor therapy, whichever occurs first.
Time frame: 12 months
Overall Survival (OS)
Time frame: 12 months
Incidence of Adverse Events
Safety will be evaluated based on the incidence of adverse events occurring during study treatment, including drug treatment and radiotherapy. Adverse events will be recorded and graded according to the National Cancer Institute Common Terminology Criter
Time frame: 12 months
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