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

Short Title: ELAINE-3


Enrollment Status: Recruiting

NCT #: NCT05696626

Specialty Area: Oncology

Condition Studied: Locally Advanced or Metastatic Breast Cancer

Age Groups: Adult; Older Adult

Phase: II


Study Information

Summary / Purpose

To find out if lasofoxifene plus abemaciclib works better than fulvestrant plus abemaciclib in treating people with ER+/HER2− breast cancer that has an ESR1 mutation and has progressed after prior CDK4/6 inhibitor therapy.

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adults 18+ years of age
  • Diagnosed with estrogen receptor positive (ER+), HER2-negative breast cancer with an ESR1 mutation that has spread beyond the breast (locally advanced or metastatic)
  • Previously received treatment with ribociclib or palbociclib

What's Involved

Participation in the study will include:
  • Treatment with either lasofoxifene plus abemaciclib, or fulvestrant plus abemaciclib
  • CT/MRI scans to check response to treatment
  • Blood and urine tests to monitor your health and treatment effects
  • Electrocardiogram (ECG) to monitor heart function
  • Questionnaires

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.

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