About this trial
This study looks at how well a new medicine called utidelone works with another medicine called capecitabine in patients with HER2-negative breast cancer that has spread to the brain. The goal is to find out how effective and safe this combination is for treating these patients. This trial is taking place at multiple centers and has two stages of treatment.
The trial's ID number is NCT06764940. This is a Phase 2 trial, meaning it is looking at how well the treatment works and how safe it is. About 120 people are expected to join this trial, and it is regulated by the FDA.
Who can join
Adults aged 18 and older, both men and women, with confirmed HER2-negative breast cancer that has spread to the brain can join. They should have no more than three previous chemotherapy treatments. The trial team will confirm eligibility based on specific health criteria and medical history.
Condition
HER2-negative Breast Cancer Patients With Brain Metastases
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be placed into different groups by chance. Some will receive utidelone alone, while others will receive a combination of utidelone and capecitabine. The treatment cycles will last for 21 days, with specific dosing schedules for each medicine based on the group they are in.
Where
This trial is running at 17 locations in the United States. 14 of them are currently recruiting.
Augusta University
Augusta, Georgia
Biosresearch Partner
Hialeah, Florida
Cancer & Blood Research Center, LLC
Los Alamitos, California
Community Clinical Trials
Kingwood, Texas
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada
D&H Cancer Research Center
Margate, Florida
FOMAT Medical Research (Network)
Oxnard, California
MD Anderson Cancer Center
Houston, Texas
The first 8 of 17 sites are listed here. The registry record has the full list.