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Rationale and Trial Design of DAWNA-FES Trial: Single-Arm Phase II Study of Endocrine Therapy With Dalpiciclib After
Ru Yao1, Yang Qu1, Zhixin Hao2
1Department of Breast Surgery, Peking Union Medical College Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Beijing China.
Background:
Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors have become a cornerstone in the first-line management of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer. Despite their clinical efficacy, most patients eventually experience disease progression, and optimal treatment strategies following CDK4/6 inhibitor resistance remain unclear. Emerging evidence suggests that switching endocrine therapy (ET) while continuing cyclin inhibition may provide additional clinical benefit. Dalpiciclib, a selective CDK4/6 inhibitor, in combination with physician-selected ET, represents a potential option in this setting. Concurrently, 16α-[18F]fluoro-17β-estradiol ([18F]FES) PET/CT, a novel imaging modality targeting estrogen receptors (ER), enables non-invasive, whole-body assessment of ER expression in metastatic lesions, offering a personalized approach to treatment selection.
Methods:
This is a prospective, single-center, single-arm Phase II clinical trial evaluating the efficacy and safety of dalpiciclib plus ET in HR+/HER2- advanced breast cancer patients who progressed on prior CDK4/6 inhibitor therapy. Forty eligible patients with confirmed metastases and at least one [18F]FES-positive lesion will be enrolled. Participants will receive dalpiciclib combined with ET as determined by the treating physician. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), and overall survival (OS).
Discussion:
Beyond evaluating efficacy, this single-center phase II trial will provide practical insight into the feasibility of [18F]FES PET/CT-guided patient selection, including standardized imaging workflows and multidisciplinary implementation in routine clinical research. Positive outcomes may support a personalized, imaging-guided strategy to prolong disease control after prior CDK4/6 inhibitor progression.
Ethical Approval And Trial Registration:
Approved by the Ethics Committee of Peking Union Medical College Hospital (Approval number: K3629); registered at ClinicalTrials. gov (NCT05613270).
Insights
This study investigates dalpiciclib plus endocrine therapy for advanced breast cancer after CDK4/6 inhibitor resistance. [18F]FES PET/CT guides patient selection for personalized treatment to extend disease control.
Area of Science:
- Oncology
- Pharmacology
- Radiology
Background:
- Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are standard for HR+/HER2- advanced breast cancer.
- Resistance to CDK4/6 inhibitors necessitates novel treatment strategies.
- Switching endocrine therapy with continued CDK4/6 inhibition shows promise.
Purpose of the Study:
- To evaluate the efficacy and safety of dalpiciclib plus endocrine therapy in patients with HR+/HER2- advanced breast cancer who progressed on prior CDK4/6 inhibitors.
- To assess the feasibility of 16α-[18F]fluoro-17β-estradiol ([18F]FES) PET/CT-guided patient selection.
- To explore a personalized, imaging-guided approach to prolong disease control.
Main Methods:
- Prospective, single-center, single-arm Phase II clinical trial.
- Enrollment of 40 eligible patients with confirmed metastases and at least one [18F]FES-positive lesion.
- Treatment with dalpiciclib combined with physician-selected endocrine therapy.
- Primary endpoint: progression-free survival (PFS).
Main Results:
- The trial is designed to evaluate efficacy and safety, with primary endpoint being progression-free survival.
- Secondary endpoints include objective response rate (ORR), disease control rate (DCR), and overall survival (OS).
- The study will provide data on the clinical benefit of dalpiciclib plus ET in this resistant population.
Conclusions:
- Dalpiciclib combined with endocrine therapy is a potential treatment option for patients with HR+/HER2- advanced breast cancer progressing on CDK4/6 inhibitors.
- [18F]FES PET/CT can guide personalized treatment selection.
- Positive outcomes may support an imaging-guided strategy to improve outcomes after CDK4/6 inhibitor progression.
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