The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 8 for:    eflapegrastim
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 30, 2023
First Posted Date  ICMJE July 18, 2023
Last Update Posted Date February 23, 2024
Actual Study Start Date  ICMJE November 7, 2023
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2023)		 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2023)
  • Duration of severe neutropenia [ Time Frame: cycle 2-5 (21 days for each cycle), 105 days ]
    number of consecutive days ANC lower than 500
  • 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
  • Incidence rate of neutropenia related death [ Time Frame: 1 year ]
    Death related chemotherapy induced neutropenia sepsis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy
Official Title  ICMJE Reducing Neutropenia Incidence by Changing the Date of Eflapegrastim Administration in Breast Cancer Patients Who Have Experienced Neutropenia After Chemotherapy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE Drug: Eflapegrastim
long-acting granulocyte-colony stimulating factor
Other Name: Rolvedon, Eflapegrastim-xnst, HM-10460A, SPI-2012
Study Arms  ICMJE
  • Active Comparator: Day1 Group
    Eflapegrastim administration on day 1 (24 hours after completion of chemotherapy)
    Intervention: Drug: Eflapegrastim
  • Experimental: Day 3 Group
    Eflapegrastim administration on day 3 (the third day after completion of chemotherapy
    Intervention: Drug: Eflapegrastim
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2023)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chief of Breast Center 82519338719 s8668s@hanmail.net
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05949333
Other Study ID Numbers  ICMJE GGAH 2022-10
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Changwan Jeon, Eunseong Medical Foundation Good GANG-AN HOSPITAL
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eunseong Medical Foundation Good GANG-AN HOSPITAL
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Hanmi Pharmaceutical Company Limited
Investigators  ICMJE
Principal Investigator: Chang Wan Jeon, Ph.D Surgical Oncologist
PRS Account Eunseong Medical Foundation Good GANG-AN HOSPITAL
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP