Ignite Creation Date:
2024-05-06 @ 8:12 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02698891
Status:
COMPLETED
Last Update Posted:
2022-05-06
First Post:
2016-03-02
Brief Title:
Avoiding Growth Factor During Paclitaxel Treatment in Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Feasibility and Safety of Avoiding Granulocyte Colony-stimulating Factor Prophylaxis During the Paclitaxel Portion of Dose Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen
Status:
COMPLETED
Status Verified Date:
2022-04
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:
This research study is testing the safety and feasibility of delivering the 4 cycles of dose-dense paclitaxel without the use of Neulasta Pegfilgrastim as a Granulocyte Colony-stimulating Factor G-CSF support The research study is for participants who have early stage breast cancer and have been recommended to receive a standard chemotherapy regimen doxorubicincyclophosphamide AC plus Paclitaxel T in what is called a dose-dense fashion to prevent recurrences
Detailed Description:
Low white cell blood counts increase the risk of infections thus in order to give each cycle of chemotherapy white blood cell count must have recovered adequately in between cycles Traditionally this regimen has been given with the use of a medicine called Neulasta Pegfilgrastim to speed the recovery of the white blood cell count in order to maximize the chances that the next cycle of chemotherapy can be given on time
The names of the study interventions involved in this study are
-- Neulasta Pegfilgrastim
The names of the study interventions involved in this study are
-- Neulasta Pegfilgrastim
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