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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04187898.
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.
The study will be conducted in two phases: Early Phase and Expansion Phase.
1. In the Early Phase, approximately 45 patients were enrolled and randomized in a
1:1:1 ratio to 3 dosing time schedule arms. Each cycle was of 21 days. Total 4
cycles were evaluated for this phase. On Day 1 of Cycle 1, patients received
Docetaxel and Cyclophosphamide (TC) chemotherapy followed by administration of
Eflapegrastim at 1 of 3-time schedules post-TC (30 minutes [mins], 3 hours or 5
hours). During Cycles 2-4, patients received Eflapegrastim 24 hours after TC
administration (on Day 2).
2. In the Expansion Phase, additional 45 patients will be enrolled in Cycles 1-4, who
will receive fixed dose of Eflapegrastim 30 mins after TC administration (on Day 1).
Safety evaluations will be conducted once the first 3 patients (for Early Phase) and the
first 6 patients (for Expansion Phase) have completed Cycle 1 to determine if it is safe
for patients to continue in that particular treatment arm.
Lead OrganizationSpectrum Pharmaceuticals Inc
