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

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients will receive chemotherapy every 2 weeks for up to 8 cycles (spread out of approximately 16 weeks, total) of treatment. On the day of chemotherapy treatment patients may receive an injection of darbepoetin alfa in addition to chemotherapy if their red blood cell count is below normal levels. On the day after chemotherapy treatment, patients will receive an injection of pegfilgrastim. There is one pegfilgrastim shot given per treatment cycle, for a total of 8 injections. Once the patient has finished chemotherapy and the last of the pegfilgrastim shots, their participation in this trial will be complete. While on this study the following procedures will be performed: a physical exam will be done every 2 weeks, vital signs will be done every 2 weeks, and blood tests every 2 weeks. This study also involves a Quality of Life Questionnaire done at the beginning of study treatment, at 2 months, 4 months, 6 months, and 1 year after starting the study treatment. Patients will remain on this study unless they experience unacceptable side effects from any of the treatment drugs.

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

Conditions
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Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer

Intervention / Treatment
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* Drug: Darbepoetin Alfa
* Drug: Pegfilgrastim
* Drug: Paclitaxel
* Drug: Doxorubicin
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Darbepoetin Alfa|Given day before chemotherapy of red blood cell count is below normal|
|Drug: Pegfilgrastim|Given as an injection the day before chemotherapy for a total of 8 injections|
|Drug: Paclitaxel|As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles|
|Drug: Doxorubicin|As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles|
|Drug: Cyclophosphamide|As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the rate of RBC transfusion among patients treated with dose-dense adjuvant chemotherapy receiving darbepoetin every 2 weeks. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adjuvant chemotherapy, G-CSF, pegfilgrastim, darbepoetin alfa