NCT05578053

Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer

Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer: a Multicenter, Observational, Real-world Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 420 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, observational, real-world study. We planned to recruit 420 HR+ locally advanced or metastatic breast cancer patients who had received or had not received prior systemic therapy. All patients included in the analysis were receiving or planning to receive dalpiciclib-containing regimens without restrictions, completely following the physician 's clinical choice, to assess the efficacy and safety of dalpiciclib-containing regimens.

Detailed description

All patients included in the analysis were receiving or were planning to receive dalpiciclib and other standard therapy, with no restrictions on the regimen and full adherence to physician clinical choices. Patients who qualified after completing the screening tests and assessments entered the study treatment period and were treated and visited with a dalpiciclib -containing regimen as specified in the protocol. Patients underwent imaging assessments and safety assessments according to clinical routine during study treatment, with the investigator 's assessment as the final result.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Dalpiciclib	a new, orally administered, selective CDK4/6 inhibitor

Timeline

• Start date: 2024-09-13
• Primary completion: 2028-12-01
• Completion: 2030-12-01
• First posted: 2022-10-13
• Last updated: 2025-09-11

Locations

1 site across 1 country: China