Clinical trial · Interventional
Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy
Optimal Timing and Duration of Daily G-CSF With Adjuvant TAC Chemotherapy in Node-positive Breast Cancer;Multicenter, Randomized, Open Label, Clinically IV Phase
NCT01571518CI-TRIAL-00006666unknownPhase 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)
After resection of lymph node positive breast cancer, the injection duration and timing of Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.
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 |
|---|---|---|---|
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| early leukostim | Drug | — | UNRESOLVED |
| late leukostim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- early injection
- description
- injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy
- interventionNames
- Drug: late leukostim
- type
- SHAM_COMPARATOR
- label
- late injection
- description
- injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy
- interventionNames
- Drug: early leukostim
Primary outcomes (1)
- measure
- frequency of neutropenia
- timeFrame
- Change from Baseline in neutrophil count at 21days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * primary invasive breast carcinoma with lymph node positive with curative surgery with TAC chemotherapy Exclusion Criteria: * pregnancy, * cardiovascualr disease, * abnormal renal function, * hematologic disorder
References
Publications (1)
- RESULTChan A, Fu WH, Shih V, Coyuco JC, Tan SH, Ng R. Impact of colony-stimulating factors to reduce febrile neutropenic events in breast cancer patients receiving docetaxel plus cyclophosphamide chemotherapy. Support Care Cancer. 2011 Apr;19(4):497-504. doi: 10.1007/s00520-010-0843-8. Epub 2010 Mar 17. PMID 20232087