Understanding the Benefits of Tetrathiomolybdate with Capecitabine for Breast Cancer
NCT06134375 · RecruitingThis 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.
Locations and contact
This trial is running at 3 locations in the United States. 2 of them are currently recruiting.
United States3 locations · 2 recruiting
- Dartmouth Hitchcock Medical CenterLebanon, New HampshireRecruiting
- NYU Langone perimutter Cancer CenterNew York, New YorkRecruiting
- Indiana University Simon Cancer CenterIndianapolis, IndianaNot Yet Recruiting
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.
What happens during the trial
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.
The trial team
This trial is led by Dartmouth-Hitchcock Medical Center, with Dr. Linda Vahdat as the principal investigator. The study also involves collaboration with the National Cancer Institute and other medical research programs.
Important dates
The trial started on November 26, 2024, and is currently recruiting new participants. It is expected to finish by June 26, 2036, with the main phase concluding by June 26, 2031.
Additional information
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.
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