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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).

Must not have

Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, end stage renal disease (ESRD), or psychiatric illness/social situations that would limit compliance with study requirements.

Women who are pregnant or nursing.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 days (+/- 5 days)

Summary

This trial is testing if ruxolitinib can change early abnormal breast cells that might turn into cancer. Some participants will take the drug for a short period, while others will not. Afterward, all participants will have surgery to remove the abnormal cells. Ruxolitinib has been evaluated in various clinical trials for treating certain types of breast cancer.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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My breast biopsy showed abnormal cells needing surgery.

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I agree not to take certain medications that could affect my treatment.

Exclusion Criteria

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

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I do not have any severe illnesses that could interfere with the study.

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I am not pregnant or nursing.

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I am not on HIV medication due to potential drug interactions.

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I have been treated with a JAK inhibitor before.

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I have an active Hepatitis B or C infection.

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I have been diagnosed with invasive breast cancer recently or within the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 days (+/- 5 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 days (+/- 5 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 days (+/- 5 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Apoptosis

Secondary study objectives

pSTAT5

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036

33%

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

Thrombocytosis

Upper respiratory tract infection

Hypercholesterolaemia

Haematoma

Dyslipidaemia

Pain in extremity

Abdominal discomfort

Diarrhoea

Dyspepsia

Vomiting

Blood lactate dehydrogenase increased

Memory impairment

Dyspnoea

Tinnitus

Osteoarthritis

Leukocytosis

Thrombocytopenia

Flatulence

Nausea

Sinusitis

Basal cell carcinoma

Neuropathy peripheral

Hyperuricaemia

Paraesthesia

Bronchitis

Cystitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Acute pulmonary oedema

Peripheral artery thrombosis

Vertigo

Night sweats

Intervertebral disc protrusion

Urethral stenosis

Ureterolithiasis

Localised infection

Pericardial effusion

Acute myocardial infarction

Syncope

Gastrooesophageal reflux disease

General physical health deterioration

Atrial fibrillation

Cardiac disorder

Mitral valve incompetence

Vertigo positional

Retinal artery occlusion

Visual acuity reduced

Gastrointestinal haemorrhage

Oesophageal varices haemorrhage

Lower respiratory tract infection

Pyelonephritis

Respiratory tract infection

Sepsis

Tendon rupture

Ulna fracture

Weight decreased

Decreased appetite

Hyponatraemia

Blast cell crisis

Bone marrow tumour cell infiltration

Lung adenocarcinoma

Metastases to spine

Myelofibrosis

Prostatic adenoma

Squamous cell carcinoma of skin

Nephrolithiasis

Gamma-glutamyltransferase increased

Haematocrit increased

Musculoskeletal pain

Ischaemic stroke

Diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

All Crossover Patients

Best Available Therapy

Ruxolitinib

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

~1170

0 / 8Eligibility criteria met