NCT05696626Phase 3Recruiting

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

Study sponsor: LeonaBio

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-04Estimated

Enrollment · participants600Estimated

Source updated2026-06-22Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-06-22 · 1 field changed

Planned enrollment increased by 100 participants

− Before

~~500 participants (planned)~~

+ After

600 participants (planned)

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Study details

Conditions studied

Metastatic Breast Cancer

Treatments or interventions studied

Lasofoxifene in combination with abemaciclibDrug
Fulvestrant in combination with abemaciclibDrug

Primary outcomes · main study measures

measure: Progression free survival (PFS); description: PFS is defined as the time from the date of randomization \[Visit 0 (Day 1)\] to the earliest date of first documented progression per RECIST 1.1 as determined by BICR or death due to any cause.; timeFrame: Within approximately 3 years

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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