A Phase II Study of Pegfilgrastim (Neulasta) and Darbepoetin Alfa (Aranesp) in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer

03-154

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.

2003-07-01

2007-05-01

2007-05-01

Completed

Early phase I

135

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 135, 'type': 'ACTUAL'}}

2023-08-02