NCT00146562

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Harold J. Burstein, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Breast Cancer
• Stage I Breast Cancer
• Stage II Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-07-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2005-09-07
• Last updated: 2023-08-02

Locations

6 sites across 1 country: United States