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

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

You can help another person

We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.