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NCT06134375 · ClinicalTrials.gov registry record · Phase 1

A Study of Tetrathiomolybdate (TM) Plus Capecitabine

A Phase 1 study of Triple Negative Breast Cancer and Residual Disease, sponsored by Dartmouth-Hitchcock Medical Center.

Recruiting
Registry status
Phase 1
Development phase
204
Enrollment target
1
Study location

NCT06134375 is a Phase 1 study of Triple Negative Breast Cancer and Residual Disease that is actively recruiting participants, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 204 participants, below the 245-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06134375, a Phase 1 study of Triple Negative Breast Cancer and Residual Disease, is actively recruiting participants, sponsored by Dartmouth-Hitchcock Medical Center.

RECRUITING
Registry status
Phase 1
Development phase
204 participants
Enrollment target
1
Study location

Study Summary

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.

Conditions Studied

Triple Negative Breast Cancer Residual Disease

Interventions

  • DRUG Pembrolizumab
  • DRUG Capecitabine
  • DRUG Tetrathiomolybdate

Study Locations (1)

New Hampshire

  • Dartmouth Hitchcock Medical Center - Lebanon

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2024-11-26
Est. Completion 2036-06-26
Phase Phase 1

Sponsor

Dartmouth-Hitchcock Medical Center

427 total trials

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What the Registry Record Tells You About NCT06134375

The ClinicalTrials.gov registry entry for NCT06134375 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 245-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (17% lower). The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT06134375 reports 1 study location spanning 1 distinct geographic area - top geographies include New Hampshire.

Frequently Asked Questions

What is clinical trial NCT06134375 about?

NCT06134375 is a clinical study titled "A Study of Tetrathiomolybdate (TM) Plus Capecitabine". 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 ph...

What is the current status of trial NCT06134375?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 204 participants. The study started on 2024-11-26. Estimated completion is 2036-06-26.

What conditions does trial NCT06134375 study?

This clinical trial studies the following conditions: Triple Negative Breast Cancer, Residual Disease.

What interventions are being tested in trial NCT06134375?

The interventions under investigation include: Pembrolizumab (DRUG), Capecitabine (DRUG), Tetrathiomolybdate (DRUG).

Who is sponsoring clinical trial NCT06134375?

This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06134375 being conducted?

This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.