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Phase II Study of Tetrathiomolybdate (TM) in Patients With Breast Cancer

NCT00195091 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-05-16

Study results available
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Summary

Patients with moderate to high risk primary breast cancer (Stage II with more than 4 lymph nodes involved with cancer) III or Stage IV (without evidence of disease) will take tetrathiomolybdate (TM) pills for two years.

The objectives of the study are to:

* Assess the safety and tolerability of tetrathiomolybdate in patients with breast cancer at high risk of tumor recurrence.
* Observe the disease-free survival of patients in this trial.
* Conduct background scientific experiments on tumor tissue and blood of patients in this study

Conditions

Interventions

DRUG

Tetrathiomolybdate

Induction with Tetrathiomolybdate (TM) Tetrathiomolybdate 40 mg. p.o. TID with meals and tetrathiomolybdate 60 mg at bedtime for a total of 4 doses (180 mg) per day. Induction goal Total tetrathiomolybdate dose per day = 180 mg until serum ceruloplasmin (Cp) level decreases to 5-15mg/dL. When target Cp window is reached, then the maintenance phase begins. Maintenance with Tetrathiomolybdate Total tetrathiomolybdate dose per day = 100 mg Tetrathiomolybdate 40 mg p.o. BID with meals and tetrathiomolybdate 20 mg at bedtime.

Sponsors & Collaborators

Principal Investigators

  • Linda Vahdat, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2023-03-02
Completion
2023-03-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00195091 on ClinicalTrials.gov