Tetrathiomolybdate for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast CancerTetrathiomolybdate - Drug
Eligibility
18+
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: duration of study

duration of study
time to progression for patients with breast cancer treated with study drug

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Chemoradiation and Tetrathiomolybdate (TM)
78%Leukopenia
45%Anemia
43%Nausea
32%Vomiting
28%Neutopenia
28%Constipation
17%Thrombocytopenia
10%Diarrhea
4%Diarrhea (no colostomy)
3%Anorexia
3%Thrombotic microangiopathy
3%Gastrointestinal-Other
3%Febrile neutropenia
3%Infection without neutropenia
1%Operative injury of vein/artery
1%Pleural effusion (non-malignant)
1%Wound-non-infectious
1%Cardiac-ischemia/infarction
1%Melena/GI bleeding
1%Bilirubin
1%Dehydration
1%Catheter-related infection
1%Dermatology/Skin-Other
1%Pulmonary-Other
1%Thrombosis/embolism
1%Cardiovascular/Arrhythmia-Other
1%Chest pain (non-cardiac and non-pleuritic)
1%Depressed level of consciousness
1%Hypotension
1%Colitis
1%Supraventricular arrhythmias
1%Hypokalemia
1%Ileus (or neuroconstipation)
This histogram enumerates side effects from a completed 2013 Phase 2 trial (NCT00176800) in the Chemoradiation and Tetrathiomolybdate (TM) ARM group. Side effects include: Leukopenia with 78%, Anemia with 45%, Nausea with 43%, Vomiting with 32%, Neutopenia with 28%.

Trial Design

1 Treatment Group

Tetrathiomolybdate (TM)
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Tetrathiomolybdate · No Placebo Group · Phase 2

Tetrathiomolybdate (TM)
Drug
Experimental Group · 1 Intervention: Tetrathiomolybdate · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tetrathiomolybdate
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: duration of study

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,463 Total Patients Enrolled
192 Trials studying Breast Cancer
93,719 Patients Enrolled for Breast Cancer
Weill Medical College of Cornell UniversityOTHER
989 Previous Clinical Trials
1,338,880 Total Patients Enrolled
25 Trials studying Breast Cancer
40,155 Patients Enrolled for Breast Cancer
Linda Vahdat, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
45 Total Patients Enrolled
1 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The text explains that high risk stage II breast cancer is a cancer that has at least four positive lymph nodes.
The patient must have had what is considered standard adjuvant systemic therapy that may include chemotherapy, radiation therapy, and hormonal therapy
You must wait six weeks after your last chemotherapy or radiation therapy treatment before donating blood.
The patient must have had surgery to remove the cancer from their breast
No evidence of disease after surgery and/or systemic treatment.
The patient has a greater than 3-month life expectancy.
The person has stage IV breast cancer and it is in remission
Because currently no dosing or adverse event data exist on the use of TM in patients aged 18 or younger, children are excluded from this study.
The patient has a good performance status.