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Janus Kinase (JAK) Inhibitor
Ruxolitinib for Precancerous Breast Conditions (TBCRC042 Trial)
Phase 2
Recruiting
Led By Julie Nangia, M.D.
Research Sponsored by Julie Nangia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a breast biopsy showing ADH (atypical ductal hyperplasia), ALH (atypical lobular hyperplasia), LCIS (lobular carcinoma in situ), or DCIS (ductal carcinoma in situ) requiring surgical excision. Microinvasive disease is allowed.
Willing to not use concomitant strong CYP3A4 inhibitors as this could interfere with the metabolism of ruxolitinib (i.e azole antifungals, clarithromycin, conivaptan, grapefruit juice, mibefradil, nefazodone, protease inhibitors, telithromycin).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 days (+/- 5 days)
Awards & highlights
TBCRC042 Trial Summary
This trial is testing if the drug ruxolitinib can kill premalignant breast cells. Half the participants will get the drug and half will get a placebo for 15 days, then all will have surgery to remove the cells.
Who is the study for?
This trial is for adults with certain non-invasive breast conditions like ADH, ALH, LCIS, or DCIS needing surgery. Participants must not be pregnant/nursing, HIV-positive on antiretrovirals, have had JAK inhibitors before, active hepatitis B/C, recent SERMs/aromatase inhibitors use for prevention or invasive breast cancer history within 5 years.Check my eligibility
What is being tested?
The study tests if ruxolitinib affects premalignant breast cells compared to a placebo. Half the participants will take ruxolitinib and half a sugar pill for about 15 days before surgical removal of the affected tissue.See study design
What are the potential side effects?
Ruxolitinib may cause side effects such as blood disorders (like anemia), infection risk increase due to immune system effects, liver enzyme changes indicating potential liver injury and cholesterol level alterations.
TBCRC042 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast biopsy showed abnormal cells needing surgery.
Select...
I agree not to take certain medications that could affect my treatment.
TBCRC042 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 days (+/- 5 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 days (+/- 5 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Apoptosis
Secondary outcome measures
pSTAT5
Side effects data
From 2020 Phase 3 trial • 149 Patients • NCT0203803633%
Anaemia
19%
Hypertension
17%
Nasopharyngitis
16%
Weight increased
14%
Herpes zoster
14%
Constipation
14%
Abdominal pain
14%
Headache
12%
Pruritus
12%
Back pain
12%
Epistaxis
12%
Pyrexia
12%
Dizziness
10%
Asthenia
10%
Fatigue
10%
Cough
10%
Oedema peripheral
10%
Arthralgia
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Cystitis
3%
Blood creatine phosphokinase increased
3%
Bronchitis
3%
Paraesthesia
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Localised infection
2%
Intervertebral disc protrusion
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Vertigo
2%
Peripheral artery thrombosis
2%
Ureterolithiasis
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib
TBCRC042 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RuxolitinibExperimental Treatment1 Intervention
Participants will receive ruxolitinib 20 mg by mouth twice daily for 15 days (+/- 5 days). Ruxolitinib will be supplied as four, 5 mg tablets.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a placebo (sugar pill) that is designed to mimic ruxolitinib. The placebo will be supplied as four, 5 mg tablets. Participants assigned to this arm will take four, 5 mg tablets by mouth twice daily for 15 days (+/- 5 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
Translational Breast Cancer Research ConsortiumOTHER
22 Previous Clinical Trials
2,257 Total Patients Enrolled
Julie NangiaLead Sponsor
1 Previous Clinical Trials
236 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,065 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken medication to prevent breast cancer in the last year.I do not have any severe illnesses that could interfere with the study.I am not pregnant or nursing.I am not on HIV medication due to potential drug interactions.My biopsy samples are available for research.My blood and organs are functioning well.I agree to use effective birth control or practice abstinence during the study.I have received my genetic test results before any treatment decision.My breast biopsy showed abnormal cells needing surgery.I agree not to take certain medications that could affect my treatment.I have been treated with a JAK inhibitor before.I have an active Hepatitis B or C infection.I have been diagnosed with invasive breast cancer recently or within the last 5 years.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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 participants are being studied in this investigation?
"Affirmative. Verified by the clinicaltrials.gov data, this medical trial is currently recruiting and was initially registered on May 13th 2018. Around one hundred participants are needed from 7 different sites for completion of the study."
Answered by AI
Is there any evidence that Ruxolitinib has been evaluated in other research projects?
"In 2002, the National Institutes of Health Clinical Center on Rockville Pike began studying ruxolitinib. Since then, 93 trials have been satisfactorily completed and 97 are running at present; many of which occur in Indianapolis, Indiana."
Answered by AI
What implications does the use of Ruxolitinib have for human health?
"Our team at Power assigned ruxolitinib a score of 2 since the drug is currently in Phase 2 testing. This means there have been studies showing its safety but none that prove efficacy."
Answered by AI
Are there various facilities conducting this clinical exploration in the state?
"Qualified participants in this clinical trial can be enrolled at the Indiana University Melvin and Bren Simon Cancer Center, Vanderbilt-Ingram Cancer Center, or University of Texas MD Anderson Cancer Centre. Additionally, there are 7 other sites accepting patients for the study."
Answered by AI
What medical issues is Ruxolitinib typically employed to treat?
"Ruxolitinib is an efficacious treatment for polycythemia vera, polycytemia, and hydroxyurea-resistant or -intolerant individuals."
Answered by AI
Are new participants currently being accepted into this medical experiment?
"Affirmative. Clinicaltrials.gov verifies that this medical trial, which was first shared on 13th May 2018, is currently enrolling participants. The study aims to recruit 100 individuals from 7 separate locations."
Answered by AI
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