A Study of Tetrathiomolybdate (TM) Plus Capecitabine

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

Trial Details

NCT ID
NCT06134375
Phase
PHASE1 / PHASE2
Sponsor
Dartmouth-Hitchcock Medical Center
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Tetrathiomolybdate
  • Capecitabine
  • Pembrolizumab
Locations (sample)
  • Indianapolis, Indiana, United States|39.76838,-86.15804
  • Lebanon, New Hampshire, United States|43.64229,-72.25176
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Patients must have histologically confirmed breast malignancy that is Triple negative tumors as defined as ER and PR \<1% and HER2 negative as per …
  • The patient must have completed standard neoadjuvant chemotherapy which constitutes at least 6 cycles of chemotherapy.
  • Phase Ib: Patients must have residual invasive carcinoma, at minimum in one of the following capacities: (1) node positive disease after treatment …
  • Randomized Phase 2: Patients must have residual invasive carcinoma, at minimum in one of the following capacities: (1) node positive disease after …

For full eligibility, visit ClinicalTrials.gov.

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