A Study of Tetrathiomolybdate (TM) Plus Capecitabine
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzona histologicznie przerzutująca rak piersi typu triple-negative (bez receptorów hormonalnych i HER2)
- •Ukończona chemioterapia neoadiuwantna (co najmniej 6 cykli)
- •Pozostałe nieoperacyjne zmiany nowotworowe po leczeniu (nowotwór w węzłach limfatycznych lub wysoki stopień pozostałego nowotworu)
- •Ukończona operacja chirurgiczna i radioterapia z czystymi brzegami
- •Co najmniej 2 tygodnie od ostatniej chemioterapii, co najmniej 4 tygodnie od operacji
- •Brak oznak choroby w badaniach obrazowych (tomografia, skan kości lub PET)
- •Uczestnictwo w programie leczenia zawierającym chemioterapię z antracyklinami i taksanami lub immunoterapią
- •Dla fazy Ib: kontynuacja leczenia Pembrolizumabem w fazie podtrzymującej
✗ Disqualifies
- •Wcześniejsze leczenie lekiem kapecytabina
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Last updated (source)
- April 20, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (3)
Indiana University Simon Cancer Center
Indianapolis, United States
Dartmouth Hitchcock Medical Center
Lebanon, United States
NYU Langone perimutter Cancer Center
New York, United States
Trial contact
Raven J Lavoie, RN
Naomi Kornhauser, MPH
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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