Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer (NCT00146562) | Clinical Trial Compass
CompletedPhase 2
Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer
United States135 participantsStarted 2003-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pas…
What they're measuring
1
To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks.