A Study of Tetrathiomolybdate (TM) Plus Capecitabine

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT06134375
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tetrathiomolybdate — DRUG
    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.
  • Capecitabine — DRUG
    1000mg/m2 twice daily, Days 1-14 Q21days for 6 months
  • Pembrolizumab — DRUG
    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)

Study Details

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.

Key Dates

Start date
Nov 26, 2024
Status verified
Jan 2026
Primary completion
Jun 26, 2031
Completion
Jun 26, 2036

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TM and Capecitabine with or without Pembrolizumab
    Tetrathiomolybdate (TM) and Capecitabine +/- Pembrolizumab will be administered concurrently for 6 months, TM will continue for 2.5 more years (total duration of TM treatment is 3 years)
  • Active Comparator: Capecitabine with or without Pembrolizumab
    Capecitabine +/- Pembrolizumab will be administered for 6 months (participants will remain on study for 2.5 more years).

Primary Outcome Measure

Phase 1b: To establish the safety of the combination of adjuvant tetrathiomolybdate with capecitabine and pembrolizumab by the number of dose limiting toxicities [ Time Frame: 3 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana University Simon Cancer CenterIndianapolisIndiana46202
Bryan Schneider, MD (PRINCIPAL_INVESTIGATOR)
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756
Raven Lavoie
[email protected]
(603) 653-3661
Naomi Kornhauser
[email protected]
Linda Vahdat, MD, MBA (PRINCIPAL_INVESTIGATOR)
NYU Langone perimutter Cancer CenterNew YorkNew York10016
Nancy Chan, MD
[email protected]
212-731-5349
Nancy Chen, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Indiana University Simon Cancer Center· Indianapolis, INDartmouth Hitchcock Medical Center· Lebanon, NHNYU Langone perimutter Cancer Center· New York, NY

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