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Neoadjuvant Culmerciclib Combined With Endocrine Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer

StatusRecruiting
PhasePhase 2
Started2026-09-14
View on ClinicalTrials.gov ↗

Amendment history

2026-09-16
notable
Recruitment opened
Trial started: 2026-09-14 (last estimated 2026-09-15)
This is a single-center, open-label, randomized phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant Culmerciclib combined with aromatase inhibitor versus aromatase-inhibitor monotherapy in patients with Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative early-stage breast cancer.
Trial Details
NCT Number NCT07796880
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma, Early-Stage Breast Cancer
Enrollment 80 participants
Start Date 2026-09-14
Primary Completion 2028-09-15 (estimated)
Study Completion 2033-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-09-15