CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Lasofoxifene and abemaciclib (VERZENIO (R)).drug
Likely dose
Lasofoxifene and abemaciclib (VERZENIO (R)). 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04432454
NCT04432454Phase 2Completed
CompareCT.gov

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 )

Sermonix Pharmaceuticals Inc.·interventional·Posted Jun 16, 2020·Updated Feb 13, 2025

In Brief

A Phase 2 clinical trial evaluating Lasofoxifene and abemaciclib (VERZENIO (R)). for Metastatic Breast Cancer. Completed, enrolled 29 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 16, 2020
Enrollment StartSep 29, 2020
Primary CompletionJan 28, 2025
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 6.0 years ago

Interventions

Lasofoxifene and abemaciclib (VERZENIO (R)).drug

Lasofoxifene 5 mg given once a day orally and abemaciclib 150 mg given twice a day orally.