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

Breast Cancer Clinical Trial

Official title: A Phase II Study of Tetrathiomolybdate (TM) in Patients With Breast Cancer at Moderate to High Risk of Recurrence

Status Terminated

Clinical Trial 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

Clinical Trial Description

Patients with moderate to high risk primary breast cancer -Stage III, Triple negative (T= 4 cm N0, any N+), Stage IV (without evidence of disease) will take tetrathiomolydbate (TM) pills for two years.

Extension study 1 - If patients are shown to be copper depleted, they are given the option to continue to receive TM for an additional 2 years.

Extension study 2 - Open to patients who are stage 4 NED, 10 involved lymph nodes or triple negative molecular subtype and candidates will continue for months 49-72.

Extension study 3 - Open to patients who are stage 4 NED receiving a benefit from TM. These subjects can continue receiving TM for 73-96 months.

Extension study 4 - Open to patients who are stage 4 NED receiving a benefit from TM. These subject can continue receiving TM for 97-120 months. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00195091
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: December 2003
• Completion date: March 2, 2023