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Trial record 2 of 8 for:    eflapegrastim
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Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy (NEUTHREE)

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ClinicalTrials.gov Identifier: NCT05949333
Recruitment Status : Recruiting
First Posted : July 18, 2023
Last Update Posted : February 23, 2024
Sponsor:
Collaborator:
Hanmi Pharmaceutical Company Limited
Information provided by (Responsible Party):
Changwan Jeon, Eunseong Medical Foundation Good GANG-AN HOSPITAL

Study Description
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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

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Eflapegrastim Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Neutropenia Incidence by Changing the Date of Eflapegrastim Administration in Breast Cancer Patients Who Have Experienced Neutropenia After Chemotherapy
Actual Study Start Date : November 7, 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Rolvedon, Eflapegrastim-xnst, HM-10460A, SPI-2012


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Duration of severe neutropenia [ Time Frame: cycle 2-5 (21 days for each cycle), 105 days ]
    number of consecutive days ANC lower than 500

  2. 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

  3. Incidence rate of neutropenia related death [ Time Frame: 1 year ]
    Death related chemotherapy induced neutropenia sepsis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05949333


Contacts
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Contact: Chief of Breast Center 82519338719 s8668s@hanmail.net

Locations
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Korea, Republic of
Good Gang-An Hospital Recruiting
Busan, Korea, Republic of
Contact: Chang Wan Jeon, Ph.D       s8668s@hanmai.net   
Sub-Investigator: Jangmoo Byeon, Ph.D         
Sponsors and Collaborators
Eunseong Medical Foundation Good GANG-AN HOSPITAL
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: Chang Wan Jeon, Ph.D Surgical Oncologist
More Information
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Publications:
Kaufman PA, Paroly W, Rinaldi D. Randomized double blind phase 2 study evaluating same-day vs. next-day administration of pegfilgrastim with docetaxel, doxorubicin and cyclophosphamide (TAC) in women with early stage and advanced breast cancer. Breast Cancer Res Treat 2004;88:S59.
Saven A, Schwartzberg L, Kaywin P, et al. Randomized, double-blind, phase 2, study evaluating same-day vs next-day administration of pegfilgrastim with R-CHOP in non-Hodgkin's lymphoma patients. J ClinOncol2006;24:7570.

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Responsible Party: Changwan Jeon, Chief of Breast Center, Eunseong Medical Foundation Good GANG-AN HOSPITAL
ClinicalTrials.gov Identifier: NCT05949333    
Other Study ID Numbers: GGAH 2022-10
First Posted: July 18, 2023    Key Record Dates
Last Update Posted: February 23, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Agranulocytosis
Leukopenia
Cytopenia
Hematologic Diseases
Leukocyte Disorders