Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Neutropenia Incidence by Changing the Date of Eflapegrastim Administration in Breast Cancer Patients Who Have Experienced Neutropenia After Chemotherapy

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Eflapegrastim


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Day1 Group<br>Eflapegrastim administration on day 1 (24 hours after completion of chemotherapy) | Drug: Eflapegrastim<br>* long-acting granulocyte-colony stimulating factor<br>* Other names: Rolvedon, Eflapegrastim-xnst, HM-10460A, SPI-2012;|
| Experimental: Day 3 Group<br>Eflapegrastim administration on day 3 (the third day after completion of chemotherapy | Drug: Eflapegrastim<br>* long-acting granulocyte-colony stimulating factor<br>* Other names: Rolvedon, Eflapegrastim-xnst, HM-10460A, SPI-2012;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of severe neutropenia Incidence rate of severe neutropenia | The incidence rates of Grade 4 neutropenia (ANC < 500 respectively) | cycle 2-5 (21 days for each cycle), 105 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of severe neutropenia | number of consecutive days ANC lower than 500 | cycle 2-5 (21 days for each cycle), 105 days | 
| Incidence rate of febrile neutropenia | Severe neutropenia with fever. Fever is defined as below 37.5℃ single axillary temperature 38.0℃ single ear probe temperature 38.3℃ single oral temperature 38.0℃ oral temperature over 1 hour in the absence of an obvious cause | cycle 2-5 (21 days for each cycle), 105 days | 
| Incidence rate of neutropenia related death | Death related chemotherapy induced neutropenia sepsis | 1 year |