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Trial Title:
Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy
NCT ID:
NCT05949333
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Neutropenia
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Eflapegrastim
Description:
long-acting granulocyte-colony stimulating factor
Arm group label:
Day 3 Group
Arm group label:
Day1 Group
Other name:
Rolvedon, Eflapegrastim-xnst, HM-10460A, SPI-2012
Summary:
Patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first
round are randomly assigned to either the control or experimental arm. Patients in the
control arm continue pegfilgrastim injection on day 1 while patients in the experimental
arm will receive pegfilgrastim injection on day 3 to see if changing the pegfilgrastim
administration date from day 1 to day 3 starting from the second round of chemotherapy
could reduce the incidence of neutropenia
Detailed description:
The use of pegfilgrastim, which has a long-lasting effect in the human body, after
myelosuppressive chemotherapy for solid tumors, including breast cancer, and blood
cancers has led to a decrease in the incidence of neutropenia, including febrile
neutropenia, and a reduction in medical costs by shortening hospitalization periods
related to side effects of chemotherapy. During the early stages of drug development,
there was controversy over the timing of pegfilgrastim administration, and attempts were
made to administer it at various times, from the day of chemotherapy to the day of
neutropenia began. However, based on several studies, it is now known that patients who
receive pegfilgrastim on the day of chemotherapy or after 4 days of chemotherapy have a
higher incidence of febrile neutropenia. Therefore, administering pegfilgrastim on day
1-3 after chemotherapy is ideal, but in reality, it is often difficult for patients to
visit the hospital multiple times after chemotherapy, so many patients are discharged
after receiving pegfilgrastim on day 1. The FDA and National Comprehensive Cancer Network
(NCCN) guidelines also recommend administration on day 1. It is known that patients who
experience neutropenia after the first round of chemotherapy are more likely to
experience it again in subsequent rounds. The investigators aimed to see whether changing
the pegfilgrastim administration date from day 1 to day 3 starting from the second round
of chemotherapy for patients who experienced neutropenia after receiving pegfilgrastim on
day 1 of the first round can reduce the incidence of neutropenia.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Women aged 18 to 75 years old as of the date of study registration.
- Patients with histologically confirmed invasive adenocarcinoma.
- Patients with confirmed estrogen receptor, progesterone receptor, and Her2 receptor
status.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients with a left ventricular ejection fraction (LVEF) ≥55%.
- Patients who have agreed to participate in this trial and have provided written
consent.
Exclusion Criteria:
- Patients with a history of breast cancer treatment
- Patients with a history of chemotherapy, radiation therapy, immunotherapy, or
biotherapy for malignancies other than breast cancer
- Patients with infectious diseases
- Patients with serious illnesses that may affect this clinical trial: cardiovascular
disease, kidney disease, liver disease, endocrine disease, tumors, or diabetes
- Other individuals deemed by the clinical trial investigators to be unable to
participate in the trial.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Good Gang-An Hospital
Address:
City:
Busan
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Chang Wan Jeon, Ph.D
Email:
s8668s@hanmai.net
Investigator:
Last name:
Jangmoo Byeon, Ph.D
Email:
Sub-Investigator
Start date:
November 7, 2023
Completion date:
July 2025
Lead sponsor:
Agency:
Eunseong Medical Foundation Good GANG-AN HOSPITAL
Agency class:
Other
Collaborator:
Agency:
Hanmi Pharmaceutical Company Limited
Agency class:
Industry
Source:
Eunseong Medical Foundation Good GANG-AN HOSPITAL
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05949333
