drugset / Trial / NCT05283616

Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer

NCT05283616

RandomizedParallel-groupOpen-labelTreatment

Summary

Pegfilgrastim is a long-acting recombinant human granulocyte-colony stimulating factor as support for chemotherapy, which can be used conveniently. According to the package inserts in America, Europe, and China, the recommended dose for pegfilgrastim is 6mg per cycle, while it is recommended at a dose of 3.6mg in Japan. It is still unclear whether pegfilgrastim 3mg can produce similar efficacy with pegfilgrastim 6mg. In this trial, the investigators prospectively compared the efficacy and safety of pegfilgrastim 3mg with 6mg in patients with breast cancer receiving AC regimen, a commonly used regimen in adjuvant chemotherapy for breast cancer.

Timeline

Start
2017-05-15
Primary completion
2019-10-10
Completion
2021-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegfilgrastim Protein / enzyme biologic 3 mg Subcutaneous
Subject Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous

Indications