drugset / Trial / NCT05463601
Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer
Phase 2
Active not recruiting
132 enrolled
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Jiangsu HengRui Medicine Co., Ltd. · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
Neutropenia is a common complication from dalpiciclib. Mecapegfilgramtim (code name HHPG-19K), a long-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF), has been developed. The study aim to evaluate the safety and efficiency of mecapegfilgrastim for prophylaxis of dalpiciclib -induced neutropenia in patients with advanced HR+/HER2- breast cancer.
Timeline
- Start
- 2022-08-01
- Primary completion
- 2025-01-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mecapegfilgrastim | Protein / enzyme biologic | — | — |
| Background | Dalpiciclib | Small molecule | — | — |
| Background | Exemestane | Small molecule | — | — |
| Background | Fulvestrant | Small molecule | — | — |
| Background | Letrozole | Other / unclassified | — | — |
| Background | Tamoxifen | Small molecule | — | — |