Clinical trial · Interventional
Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients
A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-dense Doxorubicin/Cyclophosphamide
NCT03575520CI-TRIAL-00033556completedPhase 2ClinicalTrials.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 is a prospective, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with pegteograstim support in Korean early breast cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin/Cyclophosphamide(AC) treatment | Drug | — | UNRESOLVED |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Peg group
- interventionNames
- Drug: Pegfilgrastim
- Drug: Doxorubicin/Cyclophosphamide(AC) treatment
Primary outcomes (1)
- measure
- the incidence of febrile neutropenia (FN)
- timeFrame
- 2months
- description
- FN is defined as neutropenia (\<500 neutrophils/μL) with a febrile event (a single oral temperature of ≥38.3°C or a temperature of ≥38.0°C sustained over a one-hour period).
Secondary outcomes (4)
- measure
- the incidences of febrile neutropenia during the first cycle of chemotherapy
- timeFrame
- At the end of Cycle 1 (each cycle is 14days)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of a primary breast cancer (stage I-III) * Age \> 18 years of age and Age \< 66 years of age * Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1 * Patients who have plan to receive neoadjuvant or adjuvant dose-dense AC chemotherapy * Adequate organ functions 1. ANC ≥1500 cells/mm3 2. PLT ≥100,000 cells/mm3 3. CCr ≥50 mL/min, or Serum Cr \<1.5 x (upper limit of normal, ULN) 4. Total bilirubin ≤1.5 x ULN 5. AST (SGOT) ≤2.5 x ULN 6. ALT (SGPT) ≤2.5 x ULN Exclusion Criteria: * Previous chemotherapy history * Previous bone marrow transplantation history * Sickle cell anemia * Radiation therapy within 4 weeks from enrollment * Previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment * Clinically significant systemic illness (serious infection, liver, kidney, heart disease) * Pregnant, breast feeding women
References
Publications (0)
Data not yet available
No reference posted for this study.