Trials / Active Not Recruiting
Active Not RecruitingNCT05463601
Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer
Efficacy and Safety of Mecapegfilgrastim for Prophylaxis of Dalpiciclib -Induced Neutropenia in Patients With Advanced HR+/HER2- Breast Cancer: a Open-label, Multicenter, Investigator-initiated, Randomized Controlled Phase II Trial
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mecapegfilgrastim | Mecapegfilgrastim |
| DRUG | dalpiciclib | dalpiciclib |
| DRUG | exemestane, fulvestrant, letrozole, tamoxifen | endocrine therapy |
Timeline
- Start date
- 2022-08-01
- Primary completion
- 2025-01-31
- Completion
- 2026-12-31
- First posted
- 2022-07-19
- Last updated
- 2025-05-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05463601. Inclusion in this directory is not an endorsement.