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 range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. serum creatinine (Scr) ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance ≥ 60 mL/min;
. total bilirubin ≤ 1.5 × ULN;
Exclusion criteria
. 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;