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Alkylating Agent
Ruxolitinib + Chemotherapy for Breast Cancer
Phase 2
Waitlist Available
Led By Filipa Lynce, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying how well Ruxolitinib works in combination with Paclitaxel, Doxorubicin, and Cyclophosphamide in treating patients with Inflammatory Breast Cancer.
Who is the study for?
This trial is for adults over 18 with triple-negative inflammatory breast cancer, who haven't had prior therapy for any breast cancer. They must be in good health with normal organ and marrow function, can have minimal metastatic disease, and agree to use contraception. Excluded are those on certain drugs or with brain metastases, HIV not on antiretrovirals, previous reactions to similar compounds as ruxolitinib, or uncontrolled illnesses.Check my eligibility
What is being tested?
The study tests Ruxolitinib combined with chemotherapy drugs Paclitaxel (Taxol), Doxorubicin (Adriamycin), and Cyclophosphamide (Cytoxan) as a treatment for Inflammatory Breast Cancer. It aims to see if this combination is effective before surgery in patients diagnosed with this aggressive form of breast cancer.See study design
What are the potential side effects?
Possible side effects include immune system suppression leading to increased infection risk; heart complications; allergic reactions; nausea and vomiting from chemotherapy; potential liver issues indicated by abnormal blood tests; fatigue; hair loss due to chemo drugs like Taxol.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess JAK Inhibition With Ruxolitinib On pStat3+ Expression
Secondary outcome measures
Asses difference in pCR rate following preoperative treatment
Assess Residual Cancer Burden (RCB) differences after preoperative therapy
Assess changes in pSTAT3 level and STAT3 gene expression following treatment
+8 moreSide 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%
Blood creatine phosphokinase increased
3%
Cystitis
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%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
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
Trial Design
3Treatment groups
Experimental Treatment
Group I: Ruxolitinib with Paclitaxel (12weeks)Experimental Treatment4 Interventions
Paclitaxel is administered with daily Ruxolitinib, followed by standard Doxorubicin and Cyclophosphamide (AC) given every 2 weeks for 4 cycles preoperatively
16 patients will be randomized from the Run-In 7 days of Ruxolitinib
The drug will be administered at a pre-determine dosage
Group II: Ruxolitinib and Paclitaxel (12weeks)Experimental Treatment4 Interventions
Paclitaxel is administered with daily Ruxolitinib, followed by standard Doxorubicin and Cyclophosphamide (AC) given every 2 weeks for 4 cycles preoperatively
32 patients will be randomized from the Run-In 7 days of Ruxolitinib + Paclitaxel
The drug will be administered at a pre-determine dosage
Group III: Paclitaxel (12weeks)Experimental Treatment4 Interventions
Paclitaxel is administered weekly followed by standard Doxorubicin and Dyclophosphamide (AC) given every 2 weeks for 4 cycles preoperatively
16 patients will be randomized from the Run-In 7 days of Ruxolitinib
The drug will be administered at a pre-determine dosage
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Paclitaxel
2011
Completed Phase 4
~5380
Doxorubicin
2012
Completed Phase 3
~7940
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,925 Total Patients Enrolled
142 Trials studying Breast Cancer
22,617 Patients Enrolled for Breast Cancer
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,142 Total Patients Enrolled
9 Trials studying Breast Cancer
647 Patients Enrolled for Breast Cancer
Filipa Lynce, MDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
196 Total Patients Enrolled
4 Trials studying Breast Cancer
174 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to drugs similar to ruxolitinib.You are taking strong CYP3A4 inhibitor medications or fluconazole.If you have HIV and are not taking specific medication for it, you cannot participate.You have not been treated with paclitaxel, doxorubicin, or cyclophosphamide for cancer.You had radiation treatment to the breast in the past.You are in good enough physical condition to carry out your normal activities or to walk and carry out light work.You have been taking high doses of corticosteroids for a long time.You have a serious condition that makes it hard for your body to absorb nutrients from food.You have breast cancer that does not have certain hormone receptors (ER and PR) and is also negative for a protein called HER2, as confirmed by specific tests.You must have been diagnosed with inflammatory breast cancer that affects your whole breast.Your heart's pumping function is normal, as measured by an echocardiogram or MUGA test.You can participate if you have breast cancer in both breasts, but only if one of them is inflammatory breast cancer and neither has been treated before.Your blood and organ functions must be within normal range, including white blood cells, platelets, liver and kidney function.Patients with a lot of spread to nearby lymph nodes can participate.You must have a confirmed diagnosis of invasive breast cancer. Any type of invasive breast cancer is allowed.Patients with only a small amount of cancer spread to the bones or organs are allowed to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib and Paclitaxel (12weeks)
- Group 2: Paclitaxel (12weeks)
- Group 3: Ruxolitinib with Paclitaxel (12weeks)
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.
Have researchers conducted any additional research focused on Ruxolitinib?
"In 1997, the medication ruxolitinib was first examined at Spectrum Health Hospital - Butterworth Campus. To date, there have been 2502 completed studies and 1772 ongoing trials located in Rochester, Minnesota."
Answered by AI
What conditions commonly respond to Ruxolitinib treatment?
"Ruxolitinib is a commonly prescribed medication for those suffering from leukemia, but it has also been used to manage metastatic bladder cancer, locally advanced non-small cell lung cancer and other forms of lung cancers."
Answered by AI
Is this research endeavor presently seeking participants?
"Unfortunately, this trial has already ceased recruitment. Initially posted on April 26th 2017 and last updated in July 9th 2022, the study is no longer accepting new participants. However, alternative studies are available; there presently exist 2290 trials recruiting patients with inflammatory breast cancer (IBC) and 1772 trials for Ruxolitinib currently enrolling applicants."
Answered by AI
Is this research novel, or has it been done before?
"According to current records, there are 1772 active studies involving ruxolitinib in 81 countries and 3615 cities. The original trial for the drug was sponsored by Alfacell in 1997 and completed its Phase 3 approval stage with 300 participants - since that time 2502 trials have concluded successfully."
Answered by AI
How many locations have been selected to carry out this experiment?
"7 medical facilities are enrolling patients in this study, including the Mayo Clinic of Rochester and Dana-Farber Cancer Institute in Boston. Additionally, MD Anderson Cancer Center in Houston is participating alongside 4 other sites."
Answered by AI
What are the implications of using Ruxolitinib for clinical care?
"Our experts at Power have assigned Ruxolitinib a safety rating of 2, since it is only in the Phase 2 trial phase and there are no studies that can support its efficacy yet."
Answered by AI
How many participants are involved in this experiment?
"This is an inactive trial posting - it was initially advertised on April 26th 2017 and most recently updated on July 9th 2021. If you are searching for other clinical studies, there are currently 2290 trials actively enrolling patients with inflammatory breast cancer (IBC) as well as 1772 tests involving Ruxolitinib that require participants."
Answered by AI
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