Clinical Trial

Efficacy and Safety of CDK4/6 Inhibitors Combined With Endocrine Therapy in HR+/HER2- Neoadjuvant Therapy for Early Breast Cancer

Active, Not Recruiting Phase 2
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Summary
This is a single arm, open label, phase 2 trial aimed to investigate the effects and safety of neoadjuvant CDK4/6 inhibitors in combination with endocrine for HR+/HER2- breast cancer. A total of 40 patients with stage II-III HR+/HER2- breast cancer will be enrolled. Six 4-week cycles of adjuvant therapy will be administrated.Premenopausal or perimenopausal patients should combine ovarian function suppression, including bilateral oophorectomy or treatment with gonadotropin-releasing hormone agonists.
Trial Details
NCT Number NCT07130643
Lead Sponsor Xinhong Wu, PhD
Conditions HR+/HER2- Breast Cancer
Enrollment 40 participants
Start Date 2024-12-20
Primary Completion 2026-12-20 (estimated)
Study Completion 2027-06-20 (estimated)
Updated on ClinicalTrials.gov 2025-08-19