Tetrathiomolybdate for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByLinda Vahdat, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?This trial involves taking tetrathiomolybdate pills for an extended period to help prevent breast cancer from coming back in patients at high risk. The medication works by lowering copper levels in the body, which some cancers need to grow.

Eligibility Criteria

This trial is for breast cancer patients with high risk of recurrence, who've completed surgery and systemic treatments like chemo or radiation. They must have no current evidence of disease, be at least six weeks post-treatment, not pregnant or breastfeeding, agree to use contraception, and have a life expectancy over three months.

Inclusion Criteria

I show no signs of cancer after treatment.

My breast cancer is advanced but not just in my bones and may be in remission.

My treatment for nerve pain has been the same for the last 2 weeks.

+8 more

Exclusion Criteria

I haven't had chemotherapy or radiotherapy in the last 6 weeks.

Serum creatinine >1.5 x normal

I have been diagnosed with breast cancer.

+4 more

Participant Groups

The study tests Tetrathiomolybdate (TM) pills taken for two years by breast cancer survivors at high risk of the cancer returning. It aims to check TM's safety and how well it prevents the cancer from coming back while also conducting scientific research on patient tissue samples.

1Treatment groups

Experimental Treatment

Group I: Tetrathiomolybdate (TM)Experimental Treatment1 Intervention

Induction period - TM 40 mg is administered three x per day with meals and TM 60 mg at bedtime for a total of 4 doses (180 mg) per day. Maintenance Period - Total TM dose per day will be in 20 mg increments to tailor the therapy to individualized patient needs to maintain the Cp level at 5-17mg/dL. Thus all dose modifications will be dependent on individual patient Cp levels. TM 40 mg p.o. BID with meals and TM 20 mg at bedtime. Subjects who have no evidence of disease (NED) and are receiving a benefit of TM can continue taking the drug for up to 120 months.

Tetrathiomolybdate is already approved in United States for the following indications:

🇺🇸 Approved in United States as Tetrathiomolybdate for: