Trial Profile

A Multicenter, Randomized, Open-Label Phase Ⅲ Trial to Compare Efficacy and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX in Patients With Breast Cancer

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 18 May 2023

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At a glance

15 May 2023 Status changed from recruiting to completed.
15 Aug 2022 According to a Luye Pharma Group media release, based on this trial, the New Drug Application (NDA) for its Goserelin Acetate Extended-release Microspheres for Injection (LY01005) for the treatment of breast cancer has been accepted by the Center for Drug Evaluation of China's National Medical Products Administration.
24 Jul 2022 According to a Luye Pharma Group media release, Primary endpoint (Non-inferiority of LY01005 compared with ZOLADEX: the percentage of subjects with serum E2 maintaining at postmenopausal level (30 pg/mL) from Week 4 to Week 12 after the first dose) has been met.

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