The purpose of this study is to compare the effect of Eflapegrastim on duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following Docetaxel and Cyclophosphamide administration.
This is a Phase 1, randomized, open label, actively-controlled study to evaluate the same day dosing of Eflapegrastim on duration of neutropenia when administered at varying intervals following Docetaxel and Cyclophosphamide (TC) chemotherapy in patients with early-stage breast cancer .
Approximately 45 patients will be enrolled and randomized in a 1:1:1 ratio to 3 dosing time schedule arms.
Each cycle will be 21 days. Total 4 cycles will be evaluated for this study. On Day 1 of Cycle 1, patients will receive Docetaxel and Cyclophosphamide (TC)chemotherapy followed by administration of Eflapegrastim at 1 of 3 time schedules post-TC (30mins, 3 hours or 5 hours). During Cycles 2-4, patients will receive Eflapegrastim 24 hours after TC administration (on Day 2).
Safety evaluations will be conducted once the first 3 patients in each arm have completed Cycle 1 to determine if it is safe for patients to continue in that particular treatment arm.
|Treatment||cyclophosphamide, docetaxel, Eflapegrastim|
|Clinical Study Identifier||NCT04187898|
|Sponsor||Spectrum Pharmaceuticals, Inc|
|Last Modified on||21 November 2020|
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