Spots Global Cancer Trial Database for Phase II Study of Tetrathiomolybdate (TM) in Patients With Breast Cancer

Study Description

Brief 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

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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