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Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer

NCT05463601 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-05-14

No results posted yet for this study

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

DRUG

Mecapegfilgrastim

Mecapegfilgrastim

DRUG

dalpiciclib

dalpiciclib

DRUG

exemestane, fulvestrant, letrozole, tamoxifen

endocrine therapy

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2025-01-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05463601 on ClinicalTrials.gov