Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer

Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283616
• Other study ID #: CH-CS-003
• Status: Completed
• Phase: Phase 3
• Start date: May 15, 2017
• Est. completion date: October 15, 2021

Study information

• Verified date: March 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 15, 2021
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Neutropenia

Intervention

Drug:
• Pegfilgrastim
Pegfilgrastim 3mg per chemotherapy cycle

Locations

Country	Name	City	State
China	Department of Medical Oncology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	febrile neutropenia in cycle1	the incidence of neutropenia with fever in cycle 1. Blood test was used and body temperature was taken.	1 month
Secondary	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
Secondary	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
Secondary	hospitalization due to neutropenia	the incidence of unplanned hospitalization due to neutropenia	1 month