Changing the timing of pegfilgrastim administration after chemotherapy to reduce neutropenia
Reducing Neutropenia Incidence by Changing the Date of Eflapegrastim Administration in Breast Cancer Patients Who Have Experienced Neutropenia After Chemotherapy
This study is testing if giving pegfilgrastim on day 3 instead of day 1 after chemotherapy can help breast cancer patients avoid low white blood cell counts and stay out of the hospital.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Eunseong Medical Foundation Good GANG-AN HOSPITAL Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Busan) |
| Trial ID | NCT05949333 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether administering pegfilgrastim on day 3 instead of day 1 after chemotherapy can reduce the incidence of neutropenia in patients with breast cancer. Patients who experienced neutropenia after receiving pegfilgrastim on day 1 during their first chemotherapy round will be randomly assigned to either continue with day 1 administration or switch to day 3 for subsequent rounds. The study aims to determine if this change in timing can lead to better patient outcomes and fewer hospitalizations due to side effects. The trial is conducted at Good Gang-An Hospital in Busan, South Korea.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 75 with histologically confirmed invasive adenocarcinoma of the breast who have experienced neutropenia after their first chemotherapy round.
Not a fit: Patients with a history of breast cancer treatment or those with serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of neutropenia and improve the quality of life for breast cancer patients undergoing chemotherapy.
How similar studies have performed: Previous studies have indicated that timing of pegfilgrastim administration can impact neutropenia rates, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Busan
- Good Gang-An Hospital — Busan, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Chang Wan Jeon, Ph.D — Surgical Oncologist
- Study coordinator: Chief of Breast Center
- Email: s8668s@hanmail.net
- Phone: 82519338719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.