Clinical trial · Interventional
Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer
A Phase II Study of Pegfilgrastim (Neulasta) and Darbepoetin Alfa (Aranesp) in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer
NCT00146562CI-TRIAL-00068444completedPhase 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)
The main purpose of this study is to see if pegfilgrastim (Neulasta) is safe and useful in supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell growth factor, darbepoetin alfa(Aranesp) can reduce the need for blood transfusion in chemotherapy recipients.
Conditions
Conditions (3)
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 |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Darbepoetin Alfa | Drug | — | UNRESOLVED |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks.
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- To determine the rate of RBC transfusion among patients treated with dose-dense adjuvant chemotherapy receiving darbepoetin every 2 weeks.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed breast cancer clinical stage I, II or III disease. Patients must be deemed of sufficient risk for tumor or recurrence * Patients may receive the defined adjuvant chemotherapy treatment either following definitive breast surgery or prior to definitive breast surgery * 18 years of age or older * ECOG performance status 0 or 1 * ANC \> 1,500/uL * Hemoglobin \> 9 g/dL * Platelets \> 100,000/ul * Total bilirubin less than or equal to ULN * AST/ALT \< 1.5 x ULN * Creatinine within normal institutional limits * PT/PTT \< institutional upper limit of normal * LVEF \> 50% Exclusion Criteria: * Previous cytotoxic chemotherapy or therapeutic radiation therapy * Pregnant or lactating women * Receiving any other investigational agents * Stage IV breast cancer * History of allergic reactions attributed to compounds of similar chemical or biologic composition to pegfilgrastim or darbepoetin * Previous exposure to G-CSF or pegfilgrastim or to recombinant erythropoetin-related growth factors. * On antibiotics within 72 hours of registration * Patients with immune deficiency who are at increased risk of lethal infections when treated with marrow-suppressive therapy, or HIV-positive patients receiving anti-retroviral therapy * Sickle cell disease * Known positive antibody response to any erythropoietic agent * Known hematologic diseases * Known history of hyperviscosity syndrome * Patients on lithium * RBC transfusion within past 4 weeks
References
Publications (0)
Data not yet available
No reference posted for this study.