Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer

NCT ID: NCT05283616

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-15
• Study Completion Date: 2021-10-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pegfilgrastim 3mg

Pegfilgrastim 3mg per chemotherapy cycle

Group Type: EXPERIMENTAL

Pegfilgrastim

Intervention Type: DRUG

Pegfilgrastim 3mg per chemotherapy cycle

pegfilgrastim 6mg

Pegfilgrastim 6mg per chemotherapy cycle

Group Type: ACTIVE_COMPARATOR

Pegfilgrastim

Intervention Type: DRUG

Pegfilgrastim 3mg per chemotherapy cycle

Interventions

Pegfilgrastim

Pegfilgrastim 3mg per chemotherapy cycle

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pin Zhang

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Oncology, Cancer Hospital, CAMS

Locations

Department of Medical Oncology

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CH-CS-003

Identifier Type: -

Identifier Source: org_study_id