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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new drug, tetrathiomolybdate, in patients with breast cancer who are at high risk for the cancer coming back.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
time to progression for patients with breast cancer treated with study drug
Side effects data
From 2013 Phase 2 trial • 69 Patients • NCT0017680078%
Leukopenia
45%
Anemia
43%
Nausea
32%
Vomiting
28%
Neutopenia
28%
Constipation
17%
Thrombocytopenia
10%
Diarrhea
4%
Diarrhea (no colostomy)
3%
Febrile neutropenia
3%
Anorexia
3%
Gastrointestinal-Other
3%
Infection without neutropenia
3%
Thrombotic microangiopathy
1%
Supraventricular arrhythmias
1%
Pleural effusion (non-malignant)
1%
Catheter-related infection
1%
Ileus (or neuroconstipation)
1%
Bilirubin
1%
Cardiac-ischemia/infarction
1%
Dehydration
1%
Cardiovascular/Arrhythmia-Other
1%
Wound-non-infectious
1%
Chest pain (non-cardiac and non-pleuritic)
1%
Depressed level of consciousness
1%
Melena/GI bleeding
1%
Dermatology/Skin-Other
1%
Hypotension
1%
Operative injury of vein/artery
1%
Pulmonary-Other
1%
Hypokalemia
1%
Colitis
1%
Thrombosis/embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemoradiation and Tetrathiomolybdate (TM)
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
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,570 Total Patients Enrolled
202 Trials studying Breast Cancer
81,087 Patients Enrolled for Breast Cancer
Weill Medical College of Cornell UniversityOTHER
1,054 Previous Clinical Trials
1,316,478 Total Patients Enrolled
29 Trials studying Breast Cancer
27,166 Patients Enrolled for Breast Cancer
Linda Vahdat, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
249 Total Patients Enrolled
1 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I show no signs of cancer after treatment.I haven't had chemotherapy or radiotherapy in the last 6 weeks.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.I am fully active and can carry on all my pre-disease activities without restriction.My organ and bone marrow functions are normal.I have been diagnosed with breast cancer.I have cancer in the lining of my brain or a history of brain tumors.I am HIV-positive and on combination anti-retroviral therapy.I have had surgery for my breast cancer.I am not currently taking Herceptin.I have received standard treatments like chemotherapy, hormonal therapy, and radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Tetrathiomolybdate (TM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are enrolling in this trial?
"Presently, this clinical trial is not seeking candidates. The trial was initially posted on December 1st, 2003 and was most recently updated on April 20th, 2022. However, there are 2698 studies actively looking for participants with breast cancer and 2 trials for Tetrathiomolybdate that are still recruiting patients."
Answered by AI
Can patients sign up for this clinical trial at this time?
"Unfortunately, this particular trial is no longer seeking participants. The study began on December 1st, 2003 but was most recently updated on April 20th, 2022. However, there are 2698 other trials related to breast cancer and 2 for Tetrathiomolybdate that are still enrolling patients."
Answered by AI
What potential risks are there for people who take Tetrathiomolybdate?
"While there is some data supporting Tetrathiomolybdate's safety, it is still in Phase 2 of clinical trials and has not yet been proven effective."
Answered by AI
Is Tetrathiomolybdate a new or experimental drug?
"As of now, there are 2 Tetrathiomolybdate studies that are still ongoing with 0 in Phase 3. Out of the 12 different centres conducting research on Tetrathiomolybdate, several locations are based in New york City."
Answered by AI
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