NCT06134375
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This clinical trial is studying whether adding an experimental drug called tetrathiomolybdate (TM) to standard treatment can help prevent triple-negative breast cancer from returning. TM is an oral medication that lowers copper levels in the body. Since some cancer cells and the blood vessels that support them rely on copper to grow and spread, researchers believe that reducing copper may help eliminate any microscopic cancer cells remaining after surgery. The study combines TM with capecitabine, a common chemotherapy pill, and potentially pembrolizumab, an immunotherapy drug given by vein.
You may be eligible if you have triple-negative breast cancer and have already completed at least six cycles of chemotherapy and surgery. Specifically, this trial is for patients whose pathology reports showed a significant amount of remaining cancer in the breast or lymph nodes at the time of surgery (Residual Cancer Burden class 2 or 3), which indicates a higher risk of the cancer returning. You must have finished your last chemotherapy or radiation treatment at least two weeks ago and your surgery at least four weeks ago, with no evidence of cancer currently visible on scans. You cannot participate if you have previously taken capecitabine or if you currently take the blood thinner warfarin.
Participation involves taking daily pills and attending regular clinic visits for infusions if you are also receiving immunotherapy. Your doctor can explain the differences between the two phases of the study and discuss whether your specific surgical and treatment history makes this a good option for you.
Generated · Written by an AI model from the trial’s public ClinicalTrials.gov record. Not medical advice.
There are two parts to this study. It is a phase 1b followed by a randomized phase 2 study to assess whether adding 3 years of adjuvant tetrathiomolybdate (TM) to standard 6 months treatment of adjuvant capecitabine and pembrolizumab in high risk for relapse triple negative breast cancer. In the phase 1b part of the study, TM is added to adjuvant capecitabine and pembrolizumab in high risk for relapse triple negative breast cancer (RCB 2, 3, risk for relapse \>60% at 5 years) after completion of neoadjuvant chemo-immunotherapy and surgery to establish the safety of the combination. This will be followed by a randomized phase 2 clinical trial of adjuvant TM and capecitabine vs capecitabine alone. If pembrolizumab was administered in the neoadjuvant setting, it may be continued in the adjuvant setting per investigator discretion.
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Indiana University Simon Cancer Center
Indianapolis, Indiana
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire
Raven Lavoie · (603) 653-3661 · Raven.M.Lavoie@hitchcock.org
NYU Langone perimutter Cancer Center
New York, New York
Nancy Chan, MD · 212-731-5349 · Nancy.chan29@nyulangone.org