Phase 2 Dalpiciclib Radiotherapy Breast Cancer Brain Metastases
Summary
NIH registered Phase 2 clinical trial NCT07539753 evaluating brain radiotherapy combined with dalpiciclib and endocrine therapy in 46 HR-positive/HER2-negative advanced breast cancer patients with brain metastases. The prospective open-label study will assess safety and efficacy per RECIST v1.1, with clinic visits every 3 months until disease progression or withdrawal.
What changed
NIH registered a new Phase 2 clinical trial (NCT07539753) on ClinicalTrials.gov evaluating the combination of dalpiciclib with physician's-choice endocrine therapy and brain radiotherapy (FSRT or WBRT) in HR-positive/HER2-negative advanced breast cancer patients with brain metastases. The single-arm exploratory study plans to enrol 46 participants, with radiotherapy commencing within 30 days before or after drug initiation, and treatment continuing post-radiotherapy until progression, toxicity, consent withdrawal, or investigator decision. Safety and tumour response will be assessed per RECIST v1.1 at 3-month intervals.
Healthcare providers and clinical investigators involved in breast cancer or neuro-oncology research may encounter this trial in literature reviews, investigator-initiated study pipelines, or competitive intelligence on CDK4/6 inhibitor combinations. The trial's inclusion of radiotherapy with dalpiciclib represents an active area of combination-strategy investigation for patients with limited systemic options following brain metastasis diagnosis.
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Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative Advanced Breast Cancer With Brain Metastases
Phase 2 NCT07539753 Kind: PHASE2 Apr 20, 2026
Abstract
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.
Conditions: Breast Cancer, Brain Metastases, HR+/HER2- Breast Cancer
Interventions: Dalpiciclib in combination with endocrine therapy by Physicians choice
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