Purpose of this Study
We are doing this study to find out if an experimental drug called asciminib (the study drug) is a safe and effective option for people with metastatic HER2+ breast cancer with brain metastases when it is combined with trastuzumab.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with HER2+ breast cancer that has metastases to the brain
- Have been previously treated with at least 1 line of therapy
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a combination of the study drug and the standard of care drug, trastuzumab. You will continue to take this study combination until you stop receiving a positive benefit or your doctor thinks it is no longer necessary to continue the study regimen.
The study drug is a tyrosine kinase inhibitor that works by blocking enzymes to prevent cancer cells from growing. Trastuzumab is a monoclonal antibody, which is a lab-made protein that helps slow or stop the growth of cancer cells by targeting HER2 proteins. When you finish the study regimen, you will be followed by the study team for 2 years to see how you are doing.
Locations
Duke University Hospital
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A single arm, open-label Phase Ib/II study of Asciminib in HER2+ Breast Cancer Brain Metastases (ASCENdANT)
Principal Investigator
Carey
Anders
Protocol Number
PRO00117131
NCT ID
NCT07136428
Phase
II
Enrollment Status
Pending Open to Enrollment