Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

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.

Timeline

Start

2018-04-12

Primary completion

2019-09-25

Completion

2020-03-05

Outcome

Met primary endpoint

release “pivotal Phase III study (NCT03252431) for F-627 (efbemalenograstim alpha) to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients has met its primary and secondary endpoints” evivebiotech.com ↗

release “In the GC-627-05 study, a clinical trial comparing efbemalenograstim alfa with pegfilgrastim completed in Europe and the U.S., the primary endpoint was achieved” evivebiotech.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	F-627	Protein / enzyme biologic	20 mg	Other
Comparator	Pegfilgrastim	Protein / enzyme biologic	6 mg	Other

Indications