Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT05283616

Collaborator

(none)

122

Enrollment

Location

Arms

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neutropenia	Drug: Pegfilgrastim	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 15, 2017

Actual Primary Completion Date :

Oct 10, 2019

Actual Study Completion Date :

Oct 15, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

adverse events [1 month]
the profile and incidence of adverse events. Symptoms and signs were observed; blood routine test and blood biochemistry tests were performed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medical Oncology	Beijing	Beijing	China	100021

Sponsors and Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

Principal Investigator: Pin Zhang, Department of Medical Oncology, Cancer Hospital, CAMS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05283616

Other Study ID Numbers:

CH-CS-003

First Posted:

Mar 17, 2022

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neutropenia

Study Results

No Results Posted as of Mar 17, 2022