NCT05512780

Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer

An Exploratory Clinical Study of CDK4/6 Inhibitor Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, exploratory clinical study

Detailed description

This is a single-arm, open-label, exploratory clinical study initiated by the investigator to evaluate the objective response rate (ORR), efficacy, and safety of Dalpiciclib combined with letrozole in the neoadjuvant treatment of stage Ⅱ-Ⅲ HR+/HER2- breast cancer.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Dalpiciclib	An exploratory study of a single-arm, open design All subjects enrolled will receive the following treatment: Dalpiciclib combined with Letrozole, 28 days as one cycle.

Timeline

• Start date: 2022-09-10
• Primary completion: 2023-08-10
• Completion: 2024-08-10
• First posted: 2022-08-23
• Last updated: 2022-08-23