CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 393 enrolled
Drug / intervention
F-627 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03252431
NCT03252431Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Multi-Centre, Open-Label, Fixed Dose, Neulasta® Active-Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

EVIVE Biotechnology·interventional·Posted Aug 17, 2017·Updated Jul 3, 2023

In Brief

A Phase 3 clinical trial evaluating F-627 and Neulasta for Breast Cancer and Neutropenia. Completed, enrolled 393 participants across 1 site.

Detailed Summary

This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive breast cancer receiving chemotherapy treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Neutropenia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 17, 2017
Enrollment StartApr 12, 2018
Primary CompletionSep 25, 2019
Study CompletionMar 5, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.9 years ago

Interventions

F-627drug

single dose pre-filled syringe

Neulastadrug

single dose pre-filled syringe