SMX22-002: Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called lasofoxifene (the study drug) is a safe and effective option for breast cancer. We want to see if the study drug combined with another drug called abemaciclib has better results than treatment with abemaciclib plus fulvestrant.

What is the Condition Being Studied?

Locally Advanced or Metastatic ER+/HER2- Breast Cancer

Who Can Participate in the Study?

Adults ages 18+ who:

Are diagnosed with estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer
Have a documented ESR1 gene mutation
Have not received more than 1 line of chemotherapy in the past, and not more than 2 lines of treatment altogether

For more information about who can join this study, please contact the study team at breastcl@dm.duke.edu.

Age Group

Adults

What is Involved?

If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:

One group will get the study drug plus abemaciclib
The other group will receive fulvestrant plus abemaciclib

All study participants will:

Have blood draws
Have heart scans (EKGs)
Have imaging scans
Answer questionnaires
Complete drug dosing diaries
Give us permission to store your tissue samples

After completing the study regimen, we will call you every 6 months to see how you are doing.

Study Details

Full Title

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

Principal Investigator

Rani Bansal, MD

Medical Oncologist

Protocol Number

IRB: PRO00112602

NCT: NCT05696626

Phase

Phase III

ClinicalTrials.gov

View on ClinicalTrials.gov

Enrollment Status

Open for Enrollment

Contact the Duke Recruitment Innovation Center

MyResearchPartners@duke.edu

919-681-5698