NCT06134375 A Study of Tetrathiomolybdate (TM) Plus Capecitabine
| NCT ID | NCT06134375 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Dartmouth-Hitchcock Medical Center |
| Condition | Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2024-11-26 |
| Primary Completion | 2031-06-26 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Patients must have histologically confirmed breast malignancy that is Triple negative tumors as defined as ER and PR \<1% and HER2 negative as per ASCO/CAP guidelines 2. The patient must have completed standard neoadjuvant chemotherapy which constitutes at least 6 cycles of chemotherapy. 3. Phase Ib: Patients must have residual invasive carcinoma, at minimum in one of the following capacities: (1) node positive disease after treatment without residual invasive carcinoma in the breast; (2) RCB 2 or RCB 3 MDAH Calculator; Standard therapy consists of the following: (1) Local therapy: (a) Lumpectomy or mastectomy to negative margins. (b) Sentinel lymph node biopsy or axillary node dissection; (c) Radiation therapy to breast if patient received a lumpectomy and per investigator choice if considering chest wall/extended field RT. (2) Systemic therapy: Prior chemotherapy is required for patients entered on the trial. Neoadjuvant treatment should consist of the followin
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