NCT07130643

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xinhong Wu, PhD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HR+/HER2- Breast Cancer

Interventions

Type	Name	Description
DRUG	CDK4/6 inhibitors+Endocrine Therapy	CDK4/6 inhibitors：dalpiciclib,palbociclib,abemaciclib,ribociclib

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-12-20
• Completion: 2027-06-20
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

1 site across 1 country: China