NCT05283616

Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer

A Randomized Controlled Study Comparing Different Doses of Pegfilgrastim as Support for Adjuvant Chemotherapy for Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All patients received AC regimen (epirubicin or pirarubincin in combination with cyclophosphamide) intravenously. Epirubicin 90mg/m\^2 (or pirarubicin 60mg/m\^2) and cyclophosphamide 600mg/m\^2 were administered on day 1 of the chemotherapy cycle. AC regimen was administered bi-weekly or 3-weekly. Eligible patients were randomly assigned to 3mg arm (the study arm) and 6mg arm (the control arm) in a 1:1 ratio, stratified according to body weight (≤60kg or \>60kg). Patients in the study arm and the control arm received a subcutaneous injection of 3mg PEG-rhG-CSF and 6mg, respectively, forty-eight hours after completing chemotherapy infusion.

Conditions

• Neutropenia

Interventions

Type	Name	Description
DRUG	Pegfilgrastim	Pegfilgrastim 3mg per chemotherapy cycle

Timeline

• Start date: 2017-05-15
• Primary completion: 2019-10-10
• Completion: 2021-10-15
• First posted: 2022-03-17
• Last updated: 2024-03-19

Locations

1 site across 1 country: China