Trial Profile

An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 17 May 2025

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At a glance

Drugs Lasofoxifene (Primary) ; Abemaciclib; Fulvestrant
Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
Focus Registrational; Therapeutic Use
Acronyms ELAINE 3; ELAINEIII
Sponsors Sermonix Pharmaceuticals

24 Dec 2024 According to Shanghai Henlius Biotech media release, company announced that the first patient in China has been dosed in the international multi-centre Phase 3 clinical trial of HLX78 in combination with abemaciclib.
16 Dec 2024 Planned number of patients changed from 400 to 500.
16 Dec 2024 Planned End Date changed from 1 Jun 2026 to 1 Apr 2028.

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