Clinical trial · Interventional
Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy
Reducing Neutropenia Incidence by Changing the Date of Eflapegrastim Administration in Breast Cancer Patients Who Have Experienced Neutropenia After Chemotherapy
NCT05949333CI-TRIAL-00074317NEUTHREEunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eflapegrastim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Day1 Group
- description
- Eflapegrastim administration on day 1 (24 hours after completion of chemotherapy)
- interventionNames
- Drug: Eflapegrastim
- type
- EXPERIMENTAL
- label
- Day 3 Group
- description
- Eflapegrastim administration on day 3 (the third day after completion of chemotherapy
- interventionNames
- Drug: Eflapegrastim
Primary outcomes (1)
- measure
- Incidence rate of severe neutropenia Incidence rate of severe neutropenia
- timeFrame
- cycle 2-5 (21 days for each cycle), 105 days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDMeropol 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 1378905
- BACKGROUNDRowinsky 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 8648378
- BACKGROUNDWeycker 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 28958157
- BACKGROUNDWeycker 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 27734153
- BACKGROUNDLyman 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 28484882
- BACKGROUNDKaufman 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.