Status:
COMPLETED
Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer
Lead Sponsor:
Harold J. Burstein, MD, PhD
Collaborating Sponsors:
Dana-Farber Cancer Institute
Massachusetts General Hospital
Conditions:
Breast Cancer
Stage I Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, ...
Detailed Description
* 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00146562
Start Date
July 1 2003
End Date
May 1 2007
Last Update
August 2 2023
Active Locations (6)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Faulkner Hospital
Boston, Massachusetts, United States, 02130
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215