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Clinical trialNCT06134375RecruitingPhase 1/PHASE2Interventional

A Study of Tetrathiomolybdate (TM) Plus Capecitabine

SponsorDartmouth-Hitchcock Medical CenterEnrollment204Residual DiseaseTriple Negative Breast Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, United States

    Bryan Schneider, MD
    Not, yet, recruiting
  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, United States

    Linda Vahdat, MD, MBA
    Recruiting
  • Nyu Langone Perimutter Cancer Center

    New York, New York, United States

    Nancy Chen, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
26 Nov 2024
Primary completion
26 Jun 2031
Completion
26 Jun 2036
Last update posted
20 Apr 2026
Registered enrollment
204
Registry id
NCT06134375

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.