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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 2 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 ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel
Secondary outcome measures
Assess Change in STAT3 Gene Expression Following run-in Treatment
Assess Residual Cancer Burden (RCB) Differences After Preoperative Therapy
Changes in C-reactive Protein (CRP) Plasma Levels During Treatment
+5 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%
Cystitis
3%
Bronchitis
3%
Blood creatine phosphokinase increased
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%
Vertigo
2%
Localised infection
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
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
1,080 Previous Clinical Trials
340,907 Total Patients Enrolled
142 Trials studying Breast Cancer
22,620 Patients Enrolled for Breast Cancer
Incyte CorporationIndustry Sponsor
368 Previous Clinical Trials
55,438 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.
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