About this trial
This study looks at whether adding a medicine called tetrathiomolybdate (TM) to capecitabine helps patients with high-risk triple negative breast cancer. The goal is to see if this combination can lower the chances of cancer coming back after treatment. The study has two parts: one part tests safety, and the other part compares TM with capecitabine alone.
The trial ID is NCT06134375. It is a Phase 1b and Phase 2 study, meaning it is looking at safety and how well the treatment works. The trial is FDA-regulated, and it hopes to include around 204 participants.
Who can join
Adults aged 18 to 80, both men and women, who have triple negative breast cancer and have completed certain treatments can join. Participants should have some cancer remaining after previous treatments. The trial team will confirm if each person is eligible to participate.
Conditions
Triple Negative Breast Cancer, Residual Disease
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into two groups. One group will receive tetrathiomolybdate along with capecitabine, with or without pembrolizumab. This group will get treatment for 6 months, then continue TM for 2.5 more years. The other group will receive capecitabine, with or without pembrolizumab, for the same 6 months and will remain in the study for 2.5 more years without TM.
Where
This trial is running at 3 locations in the United States. 2 of them are currently recruiting.
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire
NYU Langone perimutter Cancer Center
New York, New York
Indiana University Simon Cancer Center
Indianapolis, Indiana