NCT05949333

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 7, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

May 30, 2023

Last Update Submit

February 22, 2024

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of severe neutropenia Incidence rate of severe neutropenia

    The incidence rates of Grade 4 neutropenia (ANC \< 500 respectively)

    cycle 2-5 (21 days for each cycle), 105 days

Secondary Outcomes (3)

  • Duration of severe neutropenia

    cycle 2-5 (21 days for each cycle), 105 days

  • Incidence rate of febrile neutropenia

    cycle 2-5 (21 days for each cycle), 105 days

  • Incidence rate of neutropenia related death

    1 year

Study Arms (2)

Day1 Group

ACTIVE COMPARATOR

Eflapegrastim administration on day 1 (24 hours after completion of chemotherapy)

Drug: Eflapegrastim

Day 3 Group

EXPERIMENTAL

Eflapegrastim administration on day 3 (the third day after completion of chemotherapy

Drug: Eflapegrastim

Interventions

EflapegrastimDRUG

long-acting granulocyte-colony stimulating factor

Also known as: Rolvedon, Eflapegrastim-xnst, HM-10460A, SPI-2012
Day 3 GroupDay1 Group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Gang-An Hospital

Busan, South Korea

RECRUITING

Related Publications (10)

  • Meropol NJ, Miller LL, Korn EL, Braitman LE, MacDermott ML, Schuchter LM. Severe myelosuppression resulting from concurrent administration of granulocyte colony-stimulating factor and cytotoxic chemotherapy. J Natl Cancer Inst. 1992 Aug 5;84(15):1201-3. doi: 10.1093/jnci/84.15.1201. No abstract available.

    PMID: 1378905BACKGROUND

  • Rowinsky EK, Grochow LB, Sartorius SE, Bowling MK, Kaufmann SH, Peereboom D, Donehower RC. Phase I and pharmacologic study of high doses of the topoisomerase I inhibitor topotecan with granulocyte colony-stimulating factor in patients with solid tumors. J Clin Oncol. 1996 Apr;14(4):1224-35. doi: 10.1200/JCO.1996.14.4.1224.

    PMID: 8648378BACKGROUND

  • Weycker D, Bensink M, Lonshteyn A, Doroff R, Chandler D. Risk of chemotherapy-induced febrile neutropenia by day of pegfilgrastim prophylaxis in US clinical practice from 2010 to 2015. Curr Med Res Opin. 2017 Dec;33(12):2107-2113. doi: 10.1080/03007995.2017.1386858. Epub 2017 Oct 16.

    PMID: 28958157BACKGROUND

  • Weycker D, Li X, Tzivelekis S, Atwood M, Garcia J, Li Y, Reiner M, Lyman GH. Burden of Chemotherapy-Induced Febrile Neutropenia Hospitalizations in US Clinical Practice, by Use and Patterns of Prophylaxis with Colony-Stimulating Factor. Support Care Cancer. 2017 Feb;25(2):439-447. doi: 10.1007/s00520-016-3421-x. Epub 2016 Oct 12.

    PMID: 27734153BACKGROUND

  • Lyman GH, Allcott K, Garcia J, Stryker S, Li Y, Reiner MT, Weycker D. The effectiveness and safety of same-day versus next-day administration of long-acting granulocyte colony-stimulating factors for the prophylaxis of chemotherapy-induced neutropenia: a systematic review. Support Care Cancer. 2017 Aug;25(8):2619-2629. doi: 10.1007/s00520-017-3703-y. Epub 2017 May 8.

    PMID: 28484882BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Leonard RC, Miles D, Thomas R, Nussey F; UK Breast Cancer Neutropenia Audit Group. Impact of neutropenia on delivering planned adjuvant chemotherapy: UK audit of primary breast cancer patients. Br J Cancer. 2003 Dec 1;89(11):2062-8. doi: 10.1038/sj.bjc.6601279.

    PMID: 14647139BACKGROUND

  • Hughes WT, Armstrong D, Bodey GP, Bow EJ, Brown AE, Calandra T, Feld R, Pizzo PA, Rolston KV, Shenep JL, Young LS. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis. 2002 Mar 15;34(6):730-51. doi: 10.1086/339215. Epub 2002 Feb 13. No abstract available.

    PMID: 11850858BACKGROUND

  • Tamura K. Clinical guidelines for the management of neutropenic patients with unexplained fever in Japan: validation by the Japan Febrile Neutropenia Study Group. Int J Antimicrob Agents. 2005 Dec;26 Suppl 2:S123-7; discussion S133-40. doi: 10.1016/j.ijantimicag.2005.08.001. Epub 2005 Oct 24.

    PMID: 16249072BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eflapegrastim

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chang Wan Jeon, Ph.D

    Surgical Oncologist

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chief of Breast Center

CONTACT

82519338719s8668s@hanmail.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Breast Center

Study Record Dates

First Submitted

May 30, 2023

First Posted

July 18, 2023

Study Start

November 7, 2023

Primary Completion

January 1, 2025

Study Completion

July 1, 2025

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)