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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
127
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
Rate of Paclitaxel Treatment Completion Within 7 Weeks
Rate of participants who completed Paclitaxel treatment in 7 weeks while omitting Neulasta™ (Pegfilgrastim). Neulasta is administered based on the following pre-specified safety criteria. * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion.
Time frame: 7 Weeks
Rate of Grade 3-5 Neutropenia
Percentage of participants experiencing grade 3-5 neutropenia per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. while on treatment.
Time frame: While on study, up to 6.2 months
Rate of Grade 3-4 Toxicities, Excluding Neutropenia
Percentage of participants experiencing a grade 3 or 4 toxicity excluding grade 3 or 4 neutropenia or febrile neutropenia per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame: While on study, up to 6.2 months
Rate of Chemotherapy Dose Reductions
Percentage of participants experiencing dose reductions due to adverse events.
Time frame: While on treatment, up to 2.3 months
Percentage of Participants Who Received All Planned Chemotherapy Cycles
Percentage of Participants who received all planned chemotherapy cycles.
Time frame: While on treatment, up to 2.3 months
Rate of Hypersensitivity Reactions on Cycles 3-4 of Paclitaxel, When Steroid is Avoided
The percentage of participants who experienced a hypersensitivity reaction on cycles 3 and 4 without use of dexamethasone (a steroid)..
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: While on treatment, up to 2.3 months
Number of Participants With Dose Delays by Reason for Delay
Number of participants with dose delays due to various different adverse events. Adverse events classified using CTCAEv 4.0.
Time frame: While on treatment, up to 2.3 months
Median of Savings When Omitting Pegfilgrastim From Treatment.
An algorithm was used to estimated median and range of potential savings per 100 patients if the use of pegfilgrastim was omitted from treatment. The algorithm is designed assuming an average wholesale price in the United States ranging from $1,361 to $4,655 for myeloid growth factors such as filgrastim (8 days of growth factor support/cycle) and peg-filgrastim ($5,443 to $18,622 for 4 cycles on the basis of April 2019 Medicare Part B Drug Average Sales Price), and applying a 95.7% reduction in the use of pegfilgrastim during paclitaxel.
Time frame: While on treatment, up to 2.3 months