Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer

NCT05283616 | Completed Phase 3

• 1 other identifier: CH-CS-003
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Neutropenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• febrile neutropenia in cycle1

  1 month

• grade 3/4 neutropenia in cycle 1

  1 month

• grade 4 neutropenia in cycle 1

  1 month

• hospitalization due to neutropenia

  1 month

Other Outcomes (1)

• adverse events

  1 month

Study Arms (2)

pegfilgrastim 3mg

EXPERIMENTAL

Pegfilgrastim 3mg per chemotherapy cycle

Drug: Pegfilgrastim

pegfilgrastim 6mg

ACTIVE COMPARATOR

Pegfilgrastim 6mg per chemotherapy cycle

Drug: Pegfilgrastim

Interventions

Pegfilgrastim DRUG

Pegfilgrastim 3mg per chemotherapy cycle

pegfilgrastim 3mg; pegfilgrastim 6mg

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Department of Medical Oncology

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Neutropenia

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Pin Zhang

  Department of Medical Oncology, Cancer Hospital, CAMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 17, 2022
• Study Start: May 15, 2017
• Primary Completion: October 10, 2019
• Study Completion: October 15, 2021
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)