A Study of Tetrathiomolybdate (TM) Plus Capecitabine
Status:
Not yet recruiting
Trial end date:
2034-07-01
Target enrollment:
Participant gender:
Summary
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.