Clinical trial · Interventional
Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer
G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer
- 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)
RATIONALE: Colony-stimulating factors, such as filgrastim or pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether filgrastim or pegfilgrastim is more effective than standard treatment in preventing neutropenia in women who are receiving adjuvant chemotherapy for breast cancer. PURPOSE: Randomized phase IV trial to compare the effectiveness of filgrastim or pegfilgrastim with that of standard treatment in preventing neutropenia in women who are receiving chemotherapy after undergoing surgery for breast cancer.
Conditions
Conditions (2)
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 |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Proportion of patients achieving ≥ 85% of planned dose intensity
- measure
- Proportion of patients with ≥ 1 neutropenic event
Secondary outcomes (2)
- measure
- Dose intensity achieved
- measure
- Cost of management
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer * No locally advanced or metastatic breast cancer, including supraclavicular fossa metastases * Prior neutropenic event on current chemotherapy regimen, defined as 1 of the following: * Hospitalization due to neutropenia * Absolute neutrophil count ≤ 1.5 times upper limit of normal and considered sufficiently low to require a treatment delay or a dose reduction \> 15% of planned dose * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Not specified Renal: * Not specified Other: * No other concurrent malignancy * Considered suitable risk and fitness status to continue adjuvant chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior filgrastim (G-CSF) or pegfilgrastim Chemotherapy: * See Disease Characteristics * No prior chemotherapy other than current regimen Endocrine therapy: * Prior tamoxifen allowed Radiotherapy: * Concurrent radiotherapy allowed * No concurrent sandwich/synchronous radiotherapy (i.e., administered during a break in the chemotherapy regimen) Surgery: * See Disease Characteristics Other: * Concurrent enrollment on other licensed chemotherapy trials allowed provided G-CSF is not excluded (e.g., TACT or TANGO trials) * Concurrent enrollment in the sequential arm of the SECRAB trial allowed (synchronous arm ineligible)
References
Publications (0)
Data not yet available