What is the mechanism of action of this treatment?

Breast cancer treatments work through various mechanisms to target and destroy cancer cells. Hormone therapies, such as tamoxifen and aromatase inhibitors, block hormones like estrogen that fuel certain breast cancers. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Targeted therapies, like HER2 inhibitors, specifically target cancer cell proteins to inhibit their growth. Immunotherapy boosts the body's immune system to fight cancer. Tetrathiomolybdate, a copper chelation agent, is being studied for its ability to inhibit angiogenesis (the formation of new blood vessels) and tumor growth by reducing copper levels, which are essential for these processes. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's specific characteristics.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, including chemotherapy, hormone therapy, and targeted therapy, have a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections due to lowered white blood cell counts. Hormone therapies like tamoxifen can lead to hot flashes, vaginal dryness, and an increased risk of blood clots and endometrial cancer. Targeted therapies, such as those inhibiting angiogenesis, may cause hypertension, proteinuria, and gastrointestinal perforations. Tetrathiomolybdate, a copper chelation therapy, is being studied for its potential to inhibit tumor growth by reducing angiogenesis, but its side effects are still under investigation.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that focus on inhibiting angiogenesis and tumor growth. Notable among these are bevacizumab (Avastin), which targets vascular endothelial growth factor (VEGF) to inhibit angiogenesis, and various tyrosine kinase inhibitors like lapatinib (Tykerb) that target specific growth factor receptors involved in tumor proliferation. Additionally, hormone therapies such as tamoxifen and aromatase inhibitors (e.g., letrozole) are used to block hormone-driven tumor growth. While tetrathiomolybdate (TM) is being studied for its copper chelation properties to inhibit angiogenesis, it represents a novel approach compared to these existing therapies.

What other types of research exist?

Promising novel alternatives to Tetrathiomolybdate for breast cancer patients include: 1) Organometallic complex of ruthenium(II) [cis-RuCl2(DMSO)4]o, which has shown significant antineoplastic activity with reduced toxicity compared to cis-PDD. 2) Copper-dipeptide complexes, which have demonstrated cytotoxic effects against breast cancer cells with lower toxicity to non-tumor cells. 3) Iron chelators such as methyl [2'-(2-hydroxyphenyl)-2'-thiazoline-4'-carboxylate] (MTL) and 2'-(2-hydroxyphenyl)-2'-thiazoline-4'-carboxylic acid (TFAL), which have shown substantial antiproliferative activity in murine neoplasms.

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Copper Chelator

Tetrathiomolybdate for Breast Cancer

Phase 2

Waitlist Available

Led By Linda Vahdat, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No clinical or radiologic evidence of disease after surgery and/or systemic treatment

Patients must have histologically confirmed breast malignancy that is high risk stage II breast cancer (≥4 positive lymph nodes), stage III breast cancer (including inflammatory breast cancer), or stage IV breast cancer in complete remission (bone only not allowed unless bone scan is normal)

Must not have

Objective evidence of breast cancer

Carcinomatous meningitis or history of neoplastic parenchymal brain disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to Tetrathiomolybdate (TM), which could range from mild symptoms like nausea to more serious issues affecting organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I show no signs of cancer after treatment.

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

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I am fully active and can carry on all my pre-disease activities without restriction.

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I have had surgery for my breast cancer.

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I am not currently taking Herceptin.

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I have received standard treatments like chemotherapy, hormonal therapy, and radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with breast cancer.

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I have cancer in the lining of my brain or a history of brain tumors.

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I am HIV-positive and on combination anti-retroviral therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tetrathiomolybdate

2013

Completed Phase 3

~100

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments work through various mechanisms to target and destroy cancer cells. Hormone therapies, such as tamoxifen and aromatase inhibitors, block hormones like estrogen that fuel certain breast cancers. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Targeted therapies, like HER2 inhibitors, specifically target cancer cell proteins to inhibit their growth. Immunotherapy boosts the body's immune system to fight cancer. Tetrathiomolybdate, a copper chelation agent, is being studied for its ability to inhibit angiogenesis (the formation of new blood vessels) and tumor growth by reducing copper levels, which are essential for these processes. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's specific characteristics.

1,25-Dihydroxyvitamin D3 and the regulation of human cancer cell replication.