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A Study of Tetrathiomolybdate (TM) Plus Capecitabine

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Study sites: 1 to 3v11
  2. Re-verified, no change to tracked fieldsv10
  3. Primary completion date: Nov 26, 2029 to Jun 26, 2031
    • Study completion date: Nov 26, 2034 to Jun 26, 2036
    v9
  4. Collaborators expanded, about 9 wordsv8
  5. Primary completion date: Nov 2029 to Nov 26, 2029
    • Study completion date: Nov 2034 to Nov 26, 2034
    • Site contact updated
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2024 to Nov 26, 2024
    v6
  2. Start date: Sep 2024 to Nov 2024
    • Primary completion date: Sep 2029 to Nov 2029
    • Study completion date: Sep 2034 to Nov 2034
    v5
  3. Start date: Jul 2024 to Sep 2024
    • Primary completion date: Jul 2029 to Sep 2029
    • Study completion date: Jul 2034 to Sep 2034
    v4
  4. Start date: Mar 2024 to Jul 2024
    • Primary completion date: Mar 2029 to Jul 2029
    • Study completion date: Mar 2034 to Jul 2034
    v3
  5. Start date: Nov 2023 to Mar 2024
    • Primary completion date: Nov 2028 to Mar 2029
    • Study completion date: Nov 2033 to Mar 2034
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06134375
Lead Sponsor Dartmouth-Hitchcock Medical Center
Collaborators: National Cancer Institute (NCI), Congressionally Directed Medical Research Programs
Conditions
(from sponsor)		 Triple Negative Breast Cancer, Residual Disease
Related terms Neoplasm, Residual, Triple Negative Breast Neoplasms
Enrollment 204 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov