A Study of Tetrathiomolybdate (TM) Plus Capecitabine

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

November 26, 2024

Primary Completion Date

November 26, 2029

Study Completion Date

November 26, 2034

Conditions
Triple Negative Breast CancerResidual Disease
Interventions
DRUG

Tetrathiomolybdate

Tetrathiomolybdate (TM): Ammonium tetrathiomolybdate (TM), an oral copper lowering agent, has been established as safe in patients with Wilson's disease and advanced cancer. TM forms stable copper-molybdenum clusters sequestering copper and thereby limiting its availability, for the proper functioning of angiogenic factors, including secreted metalloenzymes. TM inhibits several copper containing enzymes including ceruloplasmin, cytochrome oxidase, tyrosinase and downregulates cytokines such as MMP9 and VEGF as well as transcription factors such as NF-kB. Both pre-clinical and clinical data suggest that TM may effectively reduce both overt and sub-clinical tumor load by both targeting the metastases initiating stem cell component of primary tumors inactivating Complex IV, shifting oxphos to glycolysis and through stromal remodeling.

DRUG

Capecitabine

1000mg/m2 twice daily, Days 1-14 Q21days for 6 months

DRUG

Pembrolizumab

If pembrolizumab was administered in the neoadjuvant setting and the oncology team chooses to continue in the adjuvant setting, standard doses will be used (200 mg IV Q3weeks or 400 mg IV Q6 weeks for one year total as per package insert)

Trial Locations (1)

03756

RECRUITING

Dartmouth Hitchcock Medical Center, Lebanon

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Congressionally Directed Medical Research Programs

FED

lead

Dartmouth-Hitchcock Medical Center

OTHER