Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00146562|
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : February 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Stage I Breast Cancer Stage II Breast Cancer||Drug: Darbepoetin Alfa Drug: Pegfilgrastim Drug: Paclitaxel Drug: Doxorubicin Drug: Cyclophosphamide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pegfilgrastim (Neulasta) and Darbepoetin Alfa (Aranesp) in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer|
|Study Start Date :||July 2003|
|Primary Completion Date :||May 2007|
|Study Completion Date :||May 2007|
Drug: Darbepoetin Alfa
- To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks. [ Time Frame: 2 years ]
- To determine the rate of RBC transfusion among patients treated with dose-dense adjuvant chemotherapy receiving darbepoetin every 2 weeks. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146562
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Boston, Massachusetts, United States, 02130|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Lowell General Hospital|
|Lowell, Massachusetts, United States, 01854|
|North Shore Cancer Center|
|Peabody, Massachusetts, United States, 01960|
|Principal Investigator:||Harold Burstein, MD, PhD||Dana-Farber Cancer Institute|