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.
prior bilateral oophorectomy; or age ≥60 years; or
age <60 years and postmenopausal status defined as at least 12 consecutive months of spontaneous amenorrhea without other pathological or physiological causes, with estradiol (E2) and follicle-stimulating hormone (FSH) levels within the postmenopausal range; or
premenopausal or perimenopausal women are also eligible if they are willing to receive treatment with an LHRH agonist during the study.
2.Histologically or cytologically confirmed HR-positive, HER2-negative breast cancer in female patients, with evidence of locally recurrent or metastatic disease that is not amenable to curative surgery or radiotherapy, and with no clinical indication for chemotherapy.
1.Prior pathological diagnosis of HER2-positive breast cancer.
2.Prior disease progression on dalpiciclib in the metastatic setting.
disease recurrence or progression within 2 years of starting adjuvant endocrine therapy; or
disease progression within 6 months of first-line endocrine therapy for advanced or metastatic disease.
Single group
Dalpiciclib
DrugDalpiciclib will be administered orally at 125 mg once daily for 21 days followed by 7 days off in a 28-day cycle.
Endocrine Therapy of Physician's Choice
DrugEndocrine therapy will be selected by the treating physician according to clinical practice.
Brain Radiotherapy
RadiationBrain radiotherapy will include fractionated stereotactic radiotherapy (FSRT) or whole-brain radiotherapy (WBRT), according to the number, size, location, and distribution of brain metastatic lesions.
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.
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).
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.
Overall Survival (OS)
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
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Nanfang Hospital, Southern Medical University
Lead sponsor
Jiangmen Central Hospital
Collaborator
Dongguan People's Hospital
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborator
Meizhou People's Hospital
Collaborator
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