NCT04432454

Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

An Open-label, Multicenter Study Evaluating the Safety of Lasofoxifene in Combination With Abemaciclib for the Treatment of Pre- and Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and Have an ESR1 Mutation ( ELAINEII )

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Sermonix Pharmaceuticals Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Lasofoxifene and abemaciclib (VERZENIO (R)).	Lasofoxifene 5 mg given once a day orally and abemaciclib 150 mg given twice a day orally.

Timeline

• Start date: 2020-09-29
• Primary completion: 2025-01-28
• Completion: 2025-01-28
• First posted: 2020-06-16
• Last updated: 2025-02-13

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study