OncoMatch/Clinical Trials/NCT06134375
A Study of Tetrathiomolybdate (TM) Plus Capecitabine
Is NCT06134375 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Tetrathiomolybdate and Capecitabine for triple negative breast cancer.
Treatment: Tetrathiomolybdate · Capecitabine · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression <1% (<1%)
Triple negative tumors as defined as ER and PR <1%
Required: PR (PGR) expression <1% (<1%)
Triple negative tumors as defined as ER and PR <1%
Required: HER2 (ERBB2) negative as per ASCO/CAP guidelines (negative)
HER2 negative as per ASCO/CAP guidelines
Disease stage
Excluded: Stage METASTATIC DISEASE
No clinical or radiologic evidence of disease after surgery and/or systemic treatment (by CT scan of chest, abdomen and pelvis and bone scan or PET scan prior to enrollment). Metastatic disease [excluded].
Performance status
KPS 90–100
Prior therapy
Must have received: chemotherapy — neoadjuvant
The patient must have completed standard neoadjuvant chemotherapy which constitutes at least 6 cycles of chemotherapy.
Must have received: anthracycline — neoadjuvant
Neoadjuvant treatment should consist of the following standard therapy: Anthracycline and taxane-based therapy (i.e. AC->T, AC->Tcarbo, Keynote 522 regimen) or a non-anthracycline based chemo and immunotherapy regimen (NeoPACT).
Must have received: taxane — neoadjuvant
Neoadjuvant treatment should consist of the following standard therapy: Anthracycline and taxane-based therapy (i.e. AC->T, AC->Tcarbo, Keynote 522 regimen) or a non-anthracycline based chemo and immunotherapy regimen (NeoPACT).
Cannot have received: capecitabine (capecitabine)
Previous treatment with capecitabine is not allowed.
Lab requirements
Blood counts
hemoglobin >10mg/dL; absolute neutrophil count >1,500/µL; platelets >100,000/µL
Kidney function
estimated creatinine clearance >= 60 ml/min
Liver function
total bilirubin <1.5 x normal institutional limits; AST (SGOT)/ALT (SGPT) <1.5 X institutional upper limit of normal
Patients must have normal organ and marrow function as defined below: * hemoglobin >10mg/dL * absolute neutrophil count >1,500/ µL * platelets >100,000/µL * total bilirubin <1.5 x normal institutional limits * AST (SGOT)/ALT (SGPT) <1.5 X institutional upper limit of normal Estimated creatinine clearance < 60 ml/min [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dartmouth Hitchcock Medical Center · Lebanon, New Hampshire
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify