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DHODH Inhibitor
Leflunomide for Triple Negative Breast Cancer
Phase 1 & 2
Recruiting
Led By Charles Shapiro, MD
Research Sponsored by Charles L Shapiro MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ and marrow function as defined below: leukocytes ≥ 3,000/mcL, Absolute neutrophil count ≥ 1,000/mcL, platelets ≥ 100,000/mcl, total bilirubin within institutional upper limit of normal (≤ ULN), AST (SGOT)/ALT (SPGT) ≤ 3 x ULN (3xULN if liver mets), Creatinine ≤ ULN, A negative serum or urine pregnancy test within 3 days of receiving Day 1 Cycle 1 of leflunomide.
Age ≥ 18.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of the drug leflunomide in women with previously treated triple negative breast cancer.
Who is the study for?
This trial is for women with metastatic triple-negative breast cancer or ER+, HER2- negative breast cancer who have undergone previous treatments. They must be over 18, not pregnant, willing to use contraception, and have a performance status of 0-2. Participants should not have had chemotherapy or radiotherapy within the last 4 weeks and must have recovered from any prior treatment side effects.Check my eligibility
What is being tested?
The study is testing Leflunomide's safety and effectiveness in treating metastatic TNBC. It's taken orally daily and targets DHODH, an enzyme that may play a role in this type of cancer. The trial has two phases: Phase I determines the maximum tolerated dose; Phase II assesses how well it works against TNBC.See study design
What are the potential side effects?
Potential side effects of Leflunomide include risk of infection due to immune system suppression, liver issues (as indicated by blood tests), diarrhea, hair loss, high blood pressure, skin reactions like rash or dry skin, and respiratory infections like pneumonia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Your blood and organ function tests must show certain levels within normal ranges, and you must have a negative pregnancy test before starting the study drug leflunomide.
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I am 18 years old or older.
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I can take care of myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Benefit Rate (CBR)
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Number of side effects
Objective Response Rate
Progression-free survival (PFS)
Side effects data
From 2015 Phase 4 trial • 400 Patients • NCT0117263933%
Upper respiratory tract infection
26%
Abdominal pain
23%
Nausea
19%
Gastroenteritis
16%
Hairloss
14%
Liver function disturbance
12%
Tendinopathy
12%
Arthralgia
9%
Vertigo
9%
Hypertension
9%
Eczema
7%
Increased transpiration
7%
Arthrosis
7%
Back pain
7%
Agitation
7%
Tooth extraction
7%
Paresthesia
7%
Pruritus
5%
Anaemia
5%
Palpitations
5%
Venous insufficiency
5%
Sjogren's disease
5%
Muscle cramps
5%
Influenza infection
5%
Fatigue
5%
Headache
5%
Bronchitis
5%
General malaise
5%
Arthritis
5%
Flushes
2%
Pyrosis
2%
Endometrioid adenocarcinoma
2%
Rotator cuff lesion
2%
Intervertebral disc disorder
2%
Bladder infection
2%
Eye infection
2%
Insomnia
2%
Diarrhoea
2%
Angina
2%
Kidney cancer malignant
2%
Pneumonia
2%
Cough
2%
Genital infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
CoBRA Slim Low Risk Group
Tight Step Up Low Risk Group
CoBRA Classic High Risk Group
CoBRA Slim High Risk Group
CoBRA Avant-garde High Risk Group
Trial Design
1Treatment groups
Experimental Treatment
Group I: LeflunomideExperimental Treatment1 Intervention
Women with HER2-negative metastatic and/or locally advanced, inoperable breast cancer.
Leflunomide tablet orally daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leflunomide
2003
Completed Phase 4
~1670
Find a Location
Who is running the clinical trial?
Charles L Shapiro MDLead Sponsor
Joseph SparanoLead Sponsor
Charles Shapiro, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
83 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses that could interfere with the study.I am 18 years old or older.I am taking denosumab or zoledronic.I do not have untreated brain metastases.You have had allergic reactions to drugs similar to leflunomide or teriflunomide.I have had immunotherapy, but not chemotherapy.I had brain surgery or radiation for cancer over 4 weeks ago and am not on steroids.I can take care of myself and perform daily activities.I haven't had chemotherapy or radiotherapy in the last 2 weeks and have recovered from any side effects from treatments over 4 weeks ago.I've had up to 3 chemotherapies and 2 antibody treatments for my metastatic breast cancer, and if ER-positive, I've also tried specific inhibitors.It has been over 4 weeks since my last cancer treatment or surgery.I agree to use approved birth control methods during and 90 days after the study.Your blood and organ function tests must show certain levels within normal ranges, and you must have a negative pregnancy test before starting the study drug leflunomide.I have a history of HIV, Hepatitis B or C, or tuberculosis.I am a woman with advanced breast cancer that is not HER2-positive.
Research Study Groups:
This trial has the following groups:- Group 1: Leflunomide
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.
To what extent is the population involved in this investigation?
"Affirmative. According to the information found on clinicaltrials.gov, this trial is still recruiting patients today. It was initially posted on April 16th 2019 and has since been updated for a final time on June 2nd 2022. A total of 54 participants need to be recruited from 3 separate sites."
Answered by AI
Are there any openings for participation in this investigation?
"Affirmative, the information on clinicaltrials.gov indicates that this experiment is currently recruiting participants. It was first publicized in April 16th 2019 and has been updated most recently in June 2nd 2022. 54 individuals must be recruited from 3 separate sites to complete the trial."
Answered by AI
Are there additional reports that discuss the use of Leflunomide?
"At present, 15 clinical trials are underway involving leflunomide; two of which are in their third phase. Most locations for these studies lie near Duarte, CA but there is a total of 22 sites conducting research on this medication."
Answered by AI
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