Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05283616
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2022-03-02
Brief Title:
Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
A Randomized Controlled Study Comparing Different Doses of Pegfilgrastim as Support for Adjuvant Chemotherapy for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 36mg 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
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 36mg 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 90mgm2 or pirarubicin 60mgm2 and cyclophosphamide 600mgm2 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 11 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
Eligible patients were randomly assigned to 3mg arm the study arm and 6mg arm the control arm in a 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None