A Study of Tetrathiomolybdate (TM) Plus Capecitabine for Triple Negative Breast Cancer
This study is looking at whether adding tetrathiomolybdate (TM) to standard treatments like capecitabine and pembrolizumab can help patients with triple negative breast cancer that has residual disease (cancer cells remaining after initial treatment). Tetrathiomolybdate is a drug that lowers copper in the body. You may be able to join if you are between 18 and 80 years old, have triple negative breast cancer (meaning your cancer is negative for estrogen receptor, progesterone receptor, and HER2), and have completed at least 6 cycles of chemotherapy before surgery. The study aims to first check the safety of this combination, and then see if adding tetrathiomolybdate improves how long people live without their cancer returning in a distant part of the body. The study is currently unclear on its recruitment status and plans to enroll 204 participants.
- Study design
- This study has two parts: a Phase 1b to check safety, followed by a randomized Phase 2 study. The Phase 2 part will compare tetrathiomolybdate plus capecitabine versus capecitabine alone.
- What's involved
- Participants in Phase 1b will receive tetrathiomolybdate, capecitabine for 6 months, and pembrolizumab. Tetrathiomolybdate will continue for a total of 3 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure safety for 3 years and distant relapse-free survival for 10 years.
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A Study of Tetrathiomolybdate (TM) Plus Capecitabine
At a glance
Conditions
NCT06134375
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshirestudy coordinator listed
Recruiting
NYU Langone perimutter Cancer Center
New York, New Yorkstudy coordinator listed
Recruiting
Indiana University Simon Cancer Center
Indianapolis, Indianano site contact published
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Linda Vahdat, MD · PRINCIPAL_INVESTIGATOR · Study Principal Investigator
Who to contact
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Inclusion
What this trial measures
- Phase 1b: To establish the safety of the combination of adjuvant tetrathiomolybdate with capecitabine and pembrolizumab by the number of dose limiting toxicities3 years
To establish the safety of the combination of adjuvant tetrathiomolybdate with capecitabine and pembrolizumab administered to patients with triple negative breast cancer after completion of neoadjuvant chemotherapy and with a non-pCR (RCB 2, 3) after standard surgery. The safe dose is defined as the dose level at which no more than 1 out of 6 patients has a DLT on Cycle 1. A dose limiting toxicity (DLT) is defined as a grade 3 hematologic toxicity or non-hematologic toxicity excluding hand foot syndrome, mucositis, or diarrhea. The DLT window is 4 weeks. All toxicities will be summarized.
- Phase 2: Distant relapse-free survival (DRFS) between TM and capecitabine versus capecitabine as measured with the STEEP system10 years
The primary endpoint of this study is distant relapse-free survival (DRFS) between TM and capecitabine versus capecitabine. The continued use of adjuvant immunotherapy with pembrolizumab is left to investigator choice. DRFS is defined in accordance with the STEEP system. This definition of DRFS, includes the following as events: distant recurrence, death from breast cancer, death from non-breast cancer or unknown causes, or any second primary invasive cancer. DRFS will be compared by arm in each of the two RCB groups separately using time-to-event analytic methods such as the log-rank test and Cox regression.