NCT06810492

The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment

A Single-arm Exploratory Study of the Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+/HER2- Early Breast Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hongmei Zheng, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer. This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.

Conditions

• Breast Cancer Stage III
• Breast Cancer Stage II

Interventions

Type	Name	Description
DRUG	Ribociclib; abemaciclib; palbociclib; Dalpiciclib	Neoadjuvant therapy: CDK4/6 inhibitor combined with endocrine, a total of 6 cycles, 1 cycle every 28 days. CDK4/6 inhibitors (choose one of the following four types): * Dalpiciclib 125 mg orally once a day d1-21 every 28 days for a cycle (3 weeks/1 week off) * Palbociclib 125 mg orally once a day, d1-21, every 28 days in cycles (3 weeks/1 week off) * Abemaciclib 150 mg orally twice daily in 28-day cycles (may be reduced to 100 mg orally twice daily if not tolerated) * Ribociclib 400 mg orally once a day in a 28-day cycle Endocrine therapy drugs: take according to the label. Premenopausal patients need to be treated for ovarian function suppression.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-30
• Completion: 2027-12-01
• First posted: 2025-02-05
• Last updated: 2025-03-17