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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Good Gang-An Hospital
RECRUITING
Busan
Contact Information
Primary
Chief of Breast Center
s8668s@hanmail.net
82519338719
Time Frame
Start Date: 2023-11-07
Estimated Completion Date: 2025-07
Participants
Target number of participants: 100
Treatments
Active_comparator: Day1 Group
Eflapegrastim administration on day 1 (24 hours after completion of chemotherapy)
Experimental: Day 3 Group
Eflapegrastim administration on day 3 (the third day after completion of chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Eunseong Medical Foundation Good GANG-AN HOSPITAL
Collaborators: Hanmi Pharmaceutical Company Limited

This content was sourced from clinicaltrials.gov