Lasofoxifene and Abemaciclib for ER+/HER2- Metastatic Breast Cancer with ESR1 Mutation
This study is comparing two treatment combinations for locally advanced or metastatic estrogen receptor positive (ER+) / human epidermal growth factor 2 negative (HER2-) breast cancer with an ESR1 mutation. You might be eligible if you are a pre- or postmenopausal woman or man whose cancer has progressed after previous treatment with an AI (aromatase inhibitor) combined with palbociclib or ribociclib. The study is testing if a combination of lasofoxifene and abemaciclib is more effective than fulvestrant and abemaciclib. The main goal is to see how long people live without their cancer growing or spreading (progression-free survival). This study plans to enroll about 600 participants, but its current status is unclear.
- Study design
- This interventional study is comparing two different drug combinations. It aims to enroll 600 participants.
- What's involved
- Participants will receive either oral lasofoxifene plus oral abemaciclib, or intramuscular fulvestrant plus oral abemaciclib.
- Compensation
- Not stated in the trial record.
- Follow-up
- Progression-free survival will be measured for approximately 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
224 sites across 41 statesWho to contact
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What this trial measures
- Progression free survival (PFS)Within approximately 3 years
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.