Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative A… (NCT07539753) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative Advanced Breast Cancer With Brain Metastases
China46 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. absolute neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10\^9/L), without growth factor support within 14 days;
✓. platelet count (PLT) ≥ 100,000/mm³ (100 × 10\^9/L), without corrective treatment within 7 days;
✓. hemoglobin (Hb) ≥ 9 g/dL (90 g/L), without corrective treatment within 7 days;
✓. serum creatinine (Scr) ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance ≥ 60 mL/min;
✓. total bilirubin ≤ 1.5 × ULN;
Exclusion criteria
What they're measuring
1
Central Nervous System Progression-Free Survival (CNS-PFS)
Timeframe: 12 months
Trial details
NCT IDNCT07539753
SponsorNanfang Hospital, Southern Medical University
. 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.
✕. serious cardiovascular events such as syncope of cardiovascular origin, pathologic ventricular arrhythmias (including but not limited to ventricular tachycardia or ventricular fibrillation), or cardiac arrest;