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

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.

Who Can Participate?

Eligibility

Adults ages 18+ who:<ul>
<li>Are diagnosed with estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer</li>
<li>Have a documented ESR1 gene mutation</li>
<li>Have not received more than 1 line of chemotherapy in the past, and not more than 2 lines of treatment altogether</li></ul>
For more information about who can join this study, please contact the study team at breastcl@dm.duke.edu.

Age Range

18-89

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

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:<ul>
<li>One group will get the study drug plus abemaciclib</li>
<li>The other group will receive fulvestrant plus abemaciclib</li></ul>
All study participants will:<ul>
<li>Have blood draws</li>
<li>Have heart scans (EKGs)</li>
<li>Have imaging scans</li>
<li>Answer questionnaires</li>
<li>Complete drug dosing diaries</li>
<li>Give us permission to store your tissue samples</li></ul>
After completing the study regimen, we will call you every 6 months to see how you are doing.

Locations

Duke University Hospital
Duke Raleigh Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

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

Carey
Anders

Protocol Number

PRO00112602

NCT ID

NCT05696626

Phase

III

Enrollment Status

Open to Enrollment