Last updated on August 2020

Open-Label Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer


Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT04187898

Find a site near you

Start Over

Pacific Shores Oncology

Long Beach, CA United States
  Connect »

Mercy Health Youngstown

Youngstown, OH United States
  Connect »

Bond & Steele Clinic, P.A.

Winter Haven, FL United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.