Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146562
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2005-09-02
Brief Title:
Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer
Sponsor:
Harold J Burstein MD PhD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Pegfilgrastim Neulasta and Darbepoetin Alfa Aranesp in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 darbepoetin alfaAranesp 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None