Clinical trial · Interventional
Treatment for Elderly Patients With High Risk Breast Cancer
An Open Label, Randomised, Multicentre Study of Pegfilgrastim in Primary Versus Secondary Prophylaxis of Neutropenia as an Adjunct to Chemotherapy in Elderly Subjects With High Risk Breast Cancer.
NCT00117910CI-TRIAL-00001460completedPhase 3ClinicalTrials.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)
This open-label, multicenter study explored primary and secondary prophylaxis treatment with a single, fixed-dose, subcutaneous (SC) injection of pegfilgrastim in elderly subjects with high-risk breast cancer receiving myelosuppressive chemotherapy. The primary objective was to provide preliminary information on the incidence of protocol defined neutropenic events in chemotherapy cycle 1.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Provide preliminary information on the incidence of protocol defined neutropenic events in chemotherapy cycle 1.
Secondary outcomes (6)
- measure
- Provide preliminary information on primary and secondary prophylaxis treatment with pegfilgrastim with respect to:
- measure
- Incidence of protocol defined neutropenic events over all cycles
- measure
- Incidence of dose reductions and dose delays of planned chemotherapy due to
- measure
- hematological toxicity
- measure
- Relative dose intensity
- measure
- Safety profile over all cycles
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: - High-risk, stage II-III breast cancer suitable for treatment with up to 6 cycles of FEC-100 - Chemotherapy - Histologically proven greater than or equal to 1 axillary nodes positive - Oestrogen receptor negative or positive - Chemotherapy naïve - VES 13 (Vulnerable Elders Survey) score less than or equal to 3 - ECOG performance status less than or equal to 2 - ANC greater than or equal to 1.5 x 10\^9/L - Platelets greater than or equal to 100 x 10\^9/L - Adequate renal function (serum creatinine less than 1.5 x upper limit of normal (ULN)) - Before any study specific procedure the subject must give written informed consent for participation in the study Exclusion Criteria: - Total serum bilirubin greater than ULN according to institutional standard - Clinically significant cardiac disease that would preclude the use of epirubicin (e.g., LVEF (left ventricular ejection fraction)) less than 45% at rest by MUGA or echocardiogram - Prior bone marrow or stem cell transplantation - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia) - History of prior malignancy other than breast cancer with the exception of curatively treated basal cell carcinoma, in situ cervical carcinoma or surgically cured malignancies - Prior radiation therapy - Active infection or administration of systemic antibiotics or anti-infectives within 72 hours before start of chemotherapy - Known hypersensitivity to E coli-derived products (e.g., Filgrastim, HUMULIN®, Insulin, L-Asparaginase, HUMATROPE®, Growth Hormone, INTRON A®) - Previous exposure to pegfilgrastim or previous entry into this study - Known HIV infection - Inability to understand the nature of the study and provide written informed consent - Subject currently enrolled in another investigational device or drug trial(s) or has received other investigational agent(s), with the exception of placebo-treated subjects, within the last 30 days - Concerns for subject's compliance with the protocol procedures
References
Publications (2)
- RESULTRomieu G, Clemens M, Mahlberg R, Fargeot P, Constenla M, Schutte M, Easton V, Skacel T, Bacon P, Brugger W. Pegfilgrastim supports delivery of FEC-100 chemotherapy in elderly patients with high risk breast cancer: a randomized phase 2 trial. Crit Rev Oncol Hematol. 2007 Oct;64(1):64-72. doi: 10.1016/j.critrevonc.2006.12.007. Epub 2007 Feb 20. PMID 17317205
- DERIVEDBrugger W, Bacon P, Lawrinson S, Romieu G. Neutrophil recovery in elderly breast cancer patients receiving adjuvant anthracycline-containing chemotherapy with pegfilgrastim support. Crit Rev Oncol Hematol. 2009 Dec;72(3):265-9. doi: 10.1016/j.critrevonc.2009.05.002. Epub 2009 Oct 23. PMID 19596586