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Feasibility and Safety of Avoiding Granulocyte Colony-stimulating Factor Prophylaxis During the Paclitaxel Portion of Dose Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen
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, doxorubicin/cyclophosphamide (AC) plus Paclitaxel (T), in what is called a "dose-dense" fashion to prevent recurrences.
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)
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber at Milford Regional Cancer Center
Milford, Massachusetts, United States
Dana-Farber Cancer Institute at South Shore
Weymouth, Massachusetts, United States
Dana-Farber/New Hampshire Oncology-Hematology
Londonderry, New Hampshire, United States
Start Date
April 7, 2016
Primary Completion Date
December 1, 2020
Completion Date
November 1, 2021
Last Updated
May 6, 2022
127
ACTUAL participants
Paclitaxel
DRUG
Neulasta
DRUG
Lead Sponsor
Dana-Farber Cancer Institute
NCT06723990
NCT06970912
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06890221