Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy (NEUTHREE)

February 22, 2024 updated by: Changwan Jeon, Eunseong Medical Foundation Good GANG-AN HOSPITAL

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of severe neutropenia Incidence rate of severe neutropenia
Time Frame: cycle 2-5 (21 days for each cycle), 105 days
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
Time Frame: cycle 2-5 (21 days for each cycle), 105 days
number of consecutive days ANC lower than 500
cycle 2-5 (21 days for each cycle), 105 days
Incidence rate of febrile neutropenia
Time Frame: 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
cycle 2-5 (21 days for each cycle), 105 days
Incidence rate of neutropenia related death
Time Frame: 1 year
Death related chemotherapy induced neutropenia sepsis
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunseong Medical Foundation Good GANG-AN HOSPITAL

Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Chang Wan Jeon, Ph.D, Surgical Oncologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

July 9, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GGAH 2022-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Clinical Trials on Eflapegrastim

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe