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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503708-10-00

Acronym

SMX 22-002

Enrollment

290

Registered

2023-11-28

Start date

2024-02-20

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic breast cancer

Brief summary

Progression free survival (PFS) is defined as the time from the date of randomization [expected at Visit 0 (Day 1)] to the earliest date of first documented disease progression or death due to any cause.

Detailed description

Objective response rate (ORR) is defined as the percentage of subjects with measurable disease at baseline whose best overall response post-randomization is either a confirmed CR or a confirmed PR according to RECIST 1.1., Overall Survival (OS) is defined as time from the date of randomization [expected at Visit 0 (Day 1)] to death due to any cause

Interventions

DRUGLasofoxifene

DRUGFulvestrant

DRUGAbemaciclib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS) is defined as the time from the date of randomization [expected at Visit 0 (Day 1)] to the earliest date of first documented disease progression or death due to any cause.	—

Secondary

Measure	Time frame
Objective response rate (ORR) is defined as the percentage of subjects with measurable disease at baseline whose best overall response post-randomization is either a confirmed CR or a confirmed PR according to RECIST 1.1., Overall Survival (OS) is defined as time from the date of randomization [expected at Visit 0 (Day 1)] to death due to any cause	—

Countries

Belgium, France, Germany, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026