Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer
Recruiting now · Phase 2
Conditions studied: HR+/HER2- Early Breast Cancer
In brief
This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant culmerciclib in combination with aromatase inhibitors in patients with highly proliferative ER-positive/HER2-negative breast cancer. All patients initially receive induction treatment with culmerciclib plus endocrine therapy, followed by on-treatment assessment of biological and clinical response. Patients demonstrating an adequate response continue the same regimen, whereas those with a suboptimal response are transitioned to alternative treatment strategies prior to surgery. This adaptive approach aims to optimize treatment selection, improve therapeutic efficacy, and avoid unnecessary exposure to ineffective therapy.
Key facts
- Study ID
- NCT07616453
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 45
- Starts
- 2026-05-06
- Expected to finish
- 2033-05-05
- Last updated by the study team
- 2026-06-01
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
Where it is running
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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