Completed PHASE3 INTERVENTIONAL 3-arm NCT02104830

Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients

Multicenter Randomized Double-blind Phase III Clinical Study Comparing the Efficacy and Safety of a Single Dose Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy

Sponsor: Biocad

Conditions Chemotherapy-induced Neutropenia

Interventions Empegfilrastim 6 mg Empegfilrastim 7.5 mg Filgrastim Placebo №1 Placebo №2

Updated 9 times since 2017 Last updated: Aug 31, 2016 Started: Sep 30, 2013 Primary completion: Jun 30, 2014 Completion: Oct 31, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Chemotherapy-induced Neutropenia and is currently completed. Biocad leads this study, which shows 9 recorded versions since 2013 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2023 — Jul 2024 [monthly]

Completed PHASE3
Dec 2022 — Jan 2023 [monthly]

Completed PHASE3

▶ Show 4 earlier versions

Jan 2021 — Dec 2022 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Sep 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Biocad

Data source: Biocad

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Arkhangelsk, Russia , Chelyabinsk, Russia , Kazan', Russia , Moscow, Russia , Nizhny Novgorod, Russia , Perm, Russia , Pyatigorsk, Russia , Saint Petersburg, Russia , Saransk, Russia , Ulyanovsk, Russia and 1 more location