Breast Neoplasms
Conditions
Brief 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.
Interventions
DRUGEflapegrastim
long-acting granulocyte-colony stimulating factor
Sponsors
Hanmi Pharmaceutical Company Limited
Eunseong Medical Foundation Good GANG-AN HOSPITAL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of severe neutropenia Incidence rate of severe neutropenia | cycle 2-5 (21 days for each cycle), 105 days | The incidence rates of Grade 4 neutropenia (ANC \< 500 respectively) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of severe neutropenia | cycle 2-5 (21 days for each cycle), 105 days | number of consecutive days ANC lower than 500 |
| Incidence rate of febrile neutropenia | cycle 2-5 (21 days for each cycle), 105 days | 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 |
| Incidence rate of neutropenia related death | 1 year | Death related chemotherapy induced neutropenia sepsis |
Countries
South Korea
Contacts
Primary ContactChief of Breast Center
Outcome results
None listed