Ruxolitinib for Ductal Carcinoma In Situ

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Baylor College of Medicine, Houston, TX
Ductal Carcinoma In Situ+12 More
Ruxolitinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called ruxolitinib may help prevent breast cancer.

See full description

Eligible Conditions

  • Ductal Carcinoma In Situ
  • Atypical Lobular Hyperplasia
  • Atypical Ductal Hyperplasia
  • Lobular Carcinoma In Situ

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Ductal Carcinoma In Situ

Study Objectives

This trial is evaluating whether Ruxolitinib will improve 1 primary outcome and 1 secondary outcome in patients with Ductal Carcinoma In Situ. Measurement will happen over the course of 15 days (+/- 5 days).

Day 15
Change in Apoptosis
pSTAT5

Trial Safety

Safety Progress

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

Other trials for Ductal Carcinoma In Situ

Side Effects for

Best Available Therapy
Pruritus
23%
Headache
12%
Diarrhoea
9%
Upper respiratory tract infection
9%
Thrombocytopenia
8%
Asthenia
8%
Fatigue
8%
Dizziness
7%
Nausea
7%
Night sweats
7%
Haematocrit increased
7%
Erythema
5%
Leukocytosis
5%
Weight decreased
5%
Constipation
5%
Influenza
5%
Decreased appetite
5%
Hypertension
4%
Arthralgia
4%
Abdominal pain upper
4%
Thrombocytosis
4%
Abdominal discomfort
3%
Cough
3%
Myalgia
3%
Tinnitus
3%
Oedema peripheral
3%
Epistaxis
3%
Dyspnoea
3%
Dyspepsia
3%
Nasopharyngitis
3%
Pain in extremity
3%
Bronchitis
3%
Pyrexia
1%
Rectal haemorrhage
1%
Flatulence
1%
Abdominal pain
1%
Anaemia
1%
Syncope
1%
Cellulitis
1%
Septic shock
1%
Hyponatraemia
1%
Extremity necrosis
1%
Musculoskeletal pain
1%
Osteoarthritis
1%
Haematoma
1%
Gastrointestinal haemorrhage
1%
Gamma-glutamyltransferase increased
1%
Bladder transitional cell carcinoma
1%
Blood lactate dehydrogenase increased
1%
Hyperuricaemia
1%
Atrial fibrillation
1%
Pneumonia
1%
Neutropenia
1%
Meningitis
1%
Vertigo
1%
Depression
1%
Myelofibrosis
1%
Respiratory failure
1%
Abdominal distension
1%
Vomiting
1%
Weight increased
1%
Muscle spasms
1%
Acute myeloid leukaemia
1%
Breast cancer
1%
Cardiac failure
1%
Renal failure
1%
Hyperleukocytosis
0%
Acute pulmonary oedema
0%
Visual acuity reduced
0%
Basal cell carcinoma
0%
Sinusitis
0%
Parathyroid tumour benign
0%
Acute myocardial infarction
0%
Mitral valve incompetence
0%
Gastrointestinal inflammation
0%
Sepsis
0%
Blood uric acid increased
0%
Metastases to spine
0%
Intervertebral disc protrusion
0%
Tendon rupture
0%
Bowen's disease
0%
Blast cell crisis
0%
Cognitive disorder
0%
Hypoxia
0%
Hypertriglyceridaemia
0%
Ulna fracture
0%
Pyonephrosis
0%
Muscle rupture
0%
Back pain
0%
Radius fracture
0%
Myocardial infarction
0%
Angina pectoris
0%
Lumbar vertebral fracture
0%
Vertigo positional
0%
Non-small cell lung cancer metastatic
0%
Paraesthesia
0%
Cholelithiasis
0%
Inguinal hernia
0%
Foot deformity
0%
Post procedural haemorrhage
0%
Spinal fracture
0%
Juvenile melanoma benign
0%
Blue toe syndrome
0%
Dyslipidaemia
0%
Hypercholesterolaemia
0%
Vision blurred
0%
Localised infection
0%
Pyelonephritis
0%
Peripheral artery occlusion
0%
Bone pain
0%
Diabetes mellitus
0%
Hip fracture
0%
Haemarthrosis
0%
Dehydration
0%
Facial neuralgia
0%
Pulmonary embolism
0%
Herpes zoster
0%
Blood creatine phosphokinase increased
0%
Skin ulcer
0%
Neuropathy peripheral
0%
Cardiac disorder
0%
Pericardial effusion
0%
Oesophageal varices haemorrhage
0%
Small intestinal obstruction
0%
Non-cardiac chest pain
0%
Cystitis
0%
Carcinoma in situ
0%
Lung adenocarcinoma
0%
Metastatic malignant melanoma
0%
Vaginal cancer
0%
Osteoporosis
0%
Gastrooesophageal reflux disease
0%
Coronary artery disease
0%
Respiratory tract infection
0%
Lower respiratory tract infection
0%
Urosepsis
0%
Blood creatinine increased
0%
Basosquamous carcinoma of skin
0%
Bone marrow tumour cell infiltration
0%
Prostate cancer
0%
Prostatic adenoma
0%
Aortic valve incompetence
0%
Ophthalmic herpes zoster
0%
Squamous cell carcinoma of skin
0%
Uterine neoplasm
0%
Glaucoma
0%
Cerebrovascular accident
0%
Epilepsy
0%
General physical health deterioration
0%
Urinary tract infection
0%
Haematuria
0%
Skin cancer
0%
Ischaemic stroke
0%
Ureterolithiasis
0%
Memory impairment
0%
Actinic keratosis
0%
Dyspnoea exertional
0%
Venous haemorrhage
0%
Renal cancer
0%
Nephrolithiasis
0%
Urethral stenosis
0%
Peripheral arterial occlusive disease
0%
Peripheral artery thrombosis
0%
Retinal artery occlusion
0%
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02038036) in the Best Available Therapy ARM group. Side effects include: Pruritus with 23%, Headache with 12%, Diarrhoea with 9%, Upper respiratory tract infection with 9%, Thrombocytopenia with 8%.

Trial Design

2 Treatment Groups

Ruxolitinib
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ruxolitinib is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Ruxolitinib
Drug
Participants will receive ruxolitinib 20 mg by mouth twice daily for 15 days (+/- 5 days). Ruxolitinib will be supplied as four, 5 mg tablets.
Placebo
Drug
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
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 days (+/- 5 days)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 15 days (+/- 5 days) for reporting.

Closest Location

Baylor College of Medicine - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.
NOTE: Tissue from the diagnostic biopsy must be accessible/available for research correlates (i.e., a tissue block or ~10 unstained slides). Due to the nature of the study, fewer slides may be accepted with prior permission from the Protocol Chair if there is insufficient tissue.
Women and men age 18 and older.
Absolute neutrophil count ≥ 1500/mm3
Hemoglobin ≥ 9.0 g/dL
Platelet levels >200 x 109/L
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
AST/ALT ≤ 2.5 x institutional ULN
Alkaline phosphatase ≤ 5 x institutional ULN
Creatinine clearance > 50 mL/min as calculated by the Cockcroft-Gault method

Patient Q&A Section

Can precancerous conditions be cured?

"Even if cure is sought for a precancerous condition, the risk of relapse is high, and survival is usually shortened. This warrants routine and regular follow-up of patients during their disease span." - Anonymous Online Contributor

Unverified Answer

What are common treatments for precancerous conditions?

"There is a lack of a standard treatment protocol developed for individuals with a pre-cancerous condition. We do not know who is most susceptible to certain risks related to treatment. What to expect from treatments for pre-cancerous conditions is dependent on the type of condition. We do not know how to address the psychosocial issues of people who are at risk of developing a pre-cancerous or cancer condition." - Anonymous Online Contributor

Unverified Answer

What is precancerous conditions?

"As the number of cancers increases, there is a more obvious relationship seen in precancerous conditions. The relationship between the occurrence of precancerous conditions and the increase of cancer incidence is even stronger than the relationship between the occurrence of cancer and the increase in incidence of precancerous conditions." - Anonymous Online Contributor

Unverified Answer

What causes precancerous conditions?

"Many possible genetic factors exist for precancerous conditions and these are discussed with the relevant literature for the five conditions examined in this study. The possibility of the condition of precancerous condition in a non-cancerous process may be explained by the assumption that the condition is caused by a combination of genetic factors, some of which are the same as those involved in the cancers. Thus, most of the observed linkages between the conditions and cancers may be because some of the same genetic components are involved in both processes." - Anonymous Online Contributor

Unverified Answer

How many people get precancerous conditions a year in the United States?

"We did not identify any national guideline or policy statement to guide clinicians who diagnose or treat patients with PC, even those patients who are at higher risk for developing PC. An update of the current national guidelines for PC is needed." - Anonymous Online Contributor

Unverified Answer

What are the signs of precancerous conditions?

"It is the case that many people present with non-specific subjective symptoms that are suggestive of many systemic diseases, particularly those that involve immunosuppression. We suggest that when non-specific symptoms present with a substantial number of clinical contacts with healthcare professionals over long periods, an investigation for systemic disease should be initiated, not only to assess for specific cancer risk factors but also to detect precancerous conditions." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of precancerous conditions?

"[Precancers and cancer develop from early alterations in epithelial tissue architecture, cell turnover, and cell death that occur prior to the development of the first neoplastic neoplastic change from pre-malignant to malignant dysplastic and then carcinoma. The development of cancer is frequently associated with a pre-malignant condition or group of pre-malignant conditions that have common etiology(s) or pathologic manifestations and progression. For the purposes of this article, conditions are considered dysplastic if there exists a probability of neoplastic progression." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of ruxolitinib?

"Many side effects of ruxolitinib had a duration of <or= 3 months. Side effects included diarrhea, fatigue, nausea, anemia, neutropenia, constipation, vomiting, abnormal liver enzymes, and peripheral edema. There were no clinically significant changes in heart rate and blood pressure when ruxolitinib was used alone. Other adverse events occurring at a higher rate during the combination trials included fever (13.5% in combination and 5.9% in monotherapy trials), rash (9.7% in combination and 1.8% in monotherapy trials), hyponatremia (5% in combination and 4.2% in monotherapy trials), cough (3." - Anonymous Online Contributor

Unverified Answer

How serious can precancerous conditions be?

"People with precancerous conditions experience a range of discomfort. Although they are often reassured and satisfied at the initial consultation, over half of them develop symptoms. If symptoms are new, those with precancerous conditions should be encouraged to keep a diary of symptoms in order to identify a pattern." - Anonymous Online Contributor

Unverified Answer

Is ruxolitinib typically used in combination with any other treatments?

"Twenty-six percent of ruxolitinib users were enrolled by their providers who were only using the drug in combination with some other drug, even though the drug could be administered alone. Ruxolitinib should be used alone or in combination with other treatments only when medically appropriate." - Anonymous Online Contributor

Unverified Answer

What is the latest research for precancerous conditions?

"There is a lot of research underway for the prevention and reversal (prevention only) of precancerous conditions. But there are many more things to learn that are of less clinical value, including the cause of cancer and other non-traditional risk factors. Please consider visiting the [Curse of precancerous conditions] page for the latest information on these conditions." - Anonymous Online Contributor

Unverified Answer

Is ruxolitinib safe for people?

"In adults, ruxolitinib (100 mg twice daily and 600 mg once daily) was well tolerated across all dose levels tested in clinical trials, and the most common side effects in people (over 10% of people) were of mild to moderate severity. In clinical trials for people with myelofibrosis, only transient elevations of hepatic aminotransferase concentrations occurred; other blood lipid and blood chemistry abnormalities have not been reported in clinical trials with ruxolitinib." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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