Study of Tetrathiomolybdate (TM) and Capecitabine for High-Risk Triple Negative Breast Cancer

Sponsor: Dartmouth-Hitchcock Medical Center

Sponsor score: 0

ClinicalTrials ID:NCT06134375

Provider View

This clinical trial is exploring whether adding a new drug, tetrathiomolybdate (TM), to the standard treatment of capecitabine and pembrolizumab can help prevent the return of high-risk triple negative breast cancer after initial treatment and surgery.

Patient Parameters

Program Overview

The study is divided into two parts. The first part (Phase 1b) will test the safety of adding TM to the standard treatment of capecitabine and pembrolizumab in patients with high-risk triple negative breast cancer who have completed initial chemotherapy and surgery. The second part (Phase 2) will compare the effectiveness of capecitabine with and without TM in preventing cancer recurrence. If pembrolizumab was used before surgery, it may continue during the study based on the doctor's decision.

Description

This study aims to see if adding TM, a drug that reduces copper levels in the body, can help overcome resistance to standard breast cancer treatments. The study is for patients with high-risk triple negative breast cancer who have completed initial chemotherapy and surgery but still have some cancer left.

In Phase 1b, patients will receive TM along with capecitabine and pembrolizumab to ensure the combination is safe. This phase will include up to 18 patients. In Phase 2, patients will be randomly assigned to receive either capecitabine alone or capecitabine with TM to see which is more effective. Up to 186 patients will participate in this phase.

The treatment involves taking capecitabine for 6 months and TM for a total of 3 years. Pembrolizumab may be continued for up to a year if previously used. The study will monitor the safety and effectiveness of these treatments in preventing cancer recurrence.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with triple negative breast cancer (ER and PR <1%, HER2 negative).
  • Completed at least 6 cycles of initial chemotherapy.
  • Have some remaining cancer after initial treatment and surgery.
  • No signs of cancer spread after surgery and treatment.
  • Not previously treated with capecitabine.
  • Adults with normal organ and bone marrow function.
  • Willing to use effective birth control during the study.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Recent chemotherapy or radiation within 2 weeks, or surgery within 4 weeks.
  • Previous treatment with capecitabine or current use of warfarin.
  • Final breast surgery more than 12 weeks ago.
  • Not planning to continue immunotherapy if started before surgery.
  • Evidence of cancer spread or brain involvement.
  • Allergic to TM or capecitabine.
  • Pregnant or breastfeeding women.
  • HIV-positive patients on certain treatments.

Locations

FACILITYZIPCITYSTATE
Dartmouth Hitchcock Medical Center03756LebanonNew Hampshire

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