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

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.

Timeline

Start

2020-09-29

Primary completion

2025-01-28

Completion

2025-01-28

Publications

• Damodaran S, O'Sullivan CC, Elkhanany A, Anderson IC, Barve M, Blau S, Cherian MA, Peguero JA, Goetz MP, Plourde PV, Portman DJ, Moore HCF. Open-label, phase II, multicenter study of lasofoxifene plus abemaciclib for treating women with metastatic ER+/HER2- breast cancer and an ESR1 mutation after disease progression on prior therapies: ELAINE 2. Ann Oncol. 2023 Dec;34(12):1131-1140. doi: 10.1016/j.annonc.2023.09.3103.
• Blau S, Peguero JA, Moore HCF, Anderson IC, Barve MA, Cherian MA, Elkhanany A, O'Sullivan CC, Moreno-Aspitia A, Plourde P, Gleich LL, Riesen K, Ezzati R, Degele M, Shulman M, Stempf SD, Sachse L, Iyer AA, Damodaran S, Cooney MM. Operational Metrics for the ELAINE 2 Study Combining a Traditional Approach With a Just-in-TIME Model. JCO Clin Cancer Inform. 2023 Jun;7:e2200164. doi: 10.1200/CCI.22.00164.

Drugs

Indications