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.
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