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

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.

Study Overview

• Status: Completed
• Conditions: Neutropenia
• Intervention / Treatment: Drug: Pegfilgrastim

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Department of Medical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• female aged 18-69 years
• diagnosed pathologically as early breast cancer
• with indication for adjuvant chemotherapy and suitable for AC regimen (epirubicin and cyclophosphamide, or pirarubicin and cyclophosphamide, planned chemotherapy with taxanes after AC regimen were allowed)
• received no prior chemotherapy (chemotherapy naïve)
• have Karnofsky performance status ≥ 80,
• baseline hemoglobin ≥90g/L, white blood cell count ≥4.0X10^9/L,ANC≥2.0X10^9/L, platelet count ≥100X10^9
• adequate cardiac, hepatic and renal function

Exclusion Criteria:

• enrolled onto or had not yet completed other investigational drug trials
• allergic to any component of PEG-rhG-CSF injection, or other biological products derived from genetically engineering Escherichia coli;
• pregnant or lactating women;
• previous large volume radiotherapy, or prior bone marrow or stem-cell transplantation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pegfilgrastim 3mg; Pegfilgrastim 3mg per chemotherapy cycle	Drug: Pegfilgrastim; Pegfilgrastim 3mg per chemotherapy cycle
Active Comparator: pegfilgrastim 6mg; Pegfilgrastim 6mg per chemotherapy cycle	Drug: Pegfilgrastim; Pegfilgrastim 3mg per chemotherapy cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
timely recovery of ANC	The proportion of patients with absolute neutrophil count (ANC) ≥2.0×10^9/L before the second chemotherapy cycle. Blood routine test was used.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
febrile neutropenia in cycle1	the incidence of neutropenia with fever in cycle 1. Blood test was used and body temperature was taken.	1 month
grade 3/4 neutropenia in cycle 1	the incidence of absolute neutrophil count (ANC) <1.0×10^9/L before the second chemotherapy cycle. Blood routine test was used.	1 month
grade 4 neutropenia in cycle 1	the incidence of absolute neutrophil count (ANC) <0.5×10^9/L before the second chemotherapy cycle. Blood routine test was used.	1 month
hospitalization due to neutropenia	the incidence of unplanned hospitalization due to neutropenia	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	the profile and incidence of adverse events. Symptoms and signs were observed; blood routine test and blood biochemistry tests were performed.	1 month

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Pin Zhang, Department of Medical Oncology, Cancer Hospital, CAMS

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): October 10, 2019
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 12, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Cytopenia; Neutropenia
• Other Study ID Numbers: CH-CS-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No