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

Phase 3 Completed 122 enrolled EVIVE Biotechnology

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy treatment.

Timeline

Start: 2016-08
Primary completion: 2017-12-20
Completion: 2017-12-20

Outcome

Met primary endpoint

paper As the lower bound of the 95% CI was > 0, superiority of efbemalenograstim alfa over placebo can be declared. PMID 38103088 ↗

release “Global Phase III Clinical Trials (NCT03252431 and NCT02872103), which met its primary and secondary endpoints” evivebiotech.com ↗

Publications

Glaspy J, Bondarenko I, Burdaeva O, Chen J, Rutty D, Li R, Wang S, Hou Q, Li S. Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial. Support Care Cancer. 2023 Dec 16;32(1):34. doi: 10.1007/s00520-023-08176-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	F-627	Protein / enzyme biologic	20 mg	Subcutaneous