Clinical trial NCT05949333: Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy
Official title: Reducing Neutropenia Incidence by Changing the Date of Eflapegrastim Administration in Breast Cancer Patients Who Have Experienced Neutropenia After Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Breast Neoplasms
Lead sponsor: Eunseong Medical Foundation Good GANG-AN HOSPITAL
Sponsor class: OTHER
Collaborators: name: Hanmi Pharmaceutical Company Limited
First posted: 2023-07-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence rate of severe neutropenia Incidence rate of severe neutropenia
timeFrame: cycle 2-5 (21 days for each cycle), 105 days
Secondary outcomes:
measure: Duration of severe neutropenia
timeFrame: cycle 2-5 (21 days for each cycle), 105 days
measure: Incidence rate of febrile neutropenia
timeFrame: cycle 2-5 (21 days for each cycle), 105 days
measure: Incidence rate of neutropenia related death
timeFrame: 1 year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Good Gang-An Hospital
Study officials:
affiliation: Surgical Oncologist
name: Chang Wan Jeon, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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