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Study identifier: NCT07616453 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer

Condition: HR+/HER2- Early Breast Cancer  ·  Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

PhasePhase 2
Planned participants45
Who can joinFemale, 18 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Yunxiang Zhou  ·  15868131018  ·  yxzhou@zju.edu.cn

Always discuss trial participation with your own doctor first.

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhou, Zhejiang, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07616453