Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harold J. Burstein, MD, PhD
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Dana-Farber Cancer Institute; Lowell General Hospital; Massachusetts General Hospital; North Shore Medical Center
• Treatments: Cyclophosphamide; Darbepoetin alfa; Doxorubicin; Paclitaxel

Criteria

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