Ruxolitinib for Inflammatory Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Inflammatory Breast CancerRuxolitinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how well Ruxolitinib works in combination with Paclitaxel, Doxorubicin, and Cyclophosphamide in treating patients with Inflammatory Breast Cancer.

Eligible Conditions
  • Inflammatory Breast Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 5 years

28 weeks
Asses difference in pCR rate following preoperative treatment
Assess changes in pSTAT3 level and STAT3 gene expression following treatment
Correlate effects on pSTAT3+ and STAT3 gene expression with pCR
Determine Pathologic Complete Response rate (pCR) after preoperative therapy
5 years
Assess Residual Cancer Burden (RCB) differences after preoperative therapy
Assess distribution of CD44+/CD24- stem cell population in tumor pre- and post-exposure to ruxolotinib
Describe changes in CRP plasma levels during treatment
Describe changes in IL-6 plasma levels during treatment
Determine efficacy defined as Disease-Free Survival (DFS)
Determine efficacy defined as Overall Survival (OS)
Determine efficacy defined as Time to Treatment Failure (TTF)
7 days
Assess JAK Inhibition With Ruxolitinib On pStat3+ Expression

Trial Safety

Safety Progress

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

Side Effects for

Best Available Therapy
23%Pruritus
12%Headache
9%Diarrhoea
9%Upper respiratory tract infection
8%Thrombocytopenia
8%Asthenia
8%Fatigue
7%Dizziness
7%Nausea
7%Night sweats
7%Haematocrit increased
5%Leukocytosis
5%Constipation
5%Influenza
5%Decreased appetite
5%Erythema
5%Weight decreased
4%Arthralgia
4%Hypertension
4%Abdominal pain upper
4%Thrombocytosis
3%Tinnitus
3%Abdominal discomfort
3%Dyspepsia
3%Oedema peripheral
3%Nasopharyngitis
3%Myalgia
3%Pain in extremity
3%Cough
3%Dyspnoea
3%Epistaxis
3%Bronchitis
1%Anaemia
1%Atrial fibrillation
1%Gastrointestinal haemorrhage
1%Rectal haemorrhage
1%Cellulitis
1%Hyponatraemia
1%Bladder transitional cell carcinoma
1%Syncope
1%Extremity necrosis
1%Abdominal pain
1%Pyrexia
1%Flatulence
1%Blood lactate dehydrogenase increased
1%Gamma-glutamyltransferase increased
1%Musculoskeletal pain
1%Hyperuricaemia
1%Osteoarthritis
1%Haematoma
1%Pneumonia
1%Septic shock
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
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

3 Treatment Groups

Paclitaxel (12weeks)
1 of 3
Ruxolitinib with Paclitaxel (12weeks)
1 of 3
Ruxolitinib and Paclitaxel (12weeks)
1 of 3

Experimental Treatment

23 Total Participants · 3 Treatment Groups

Primary Treatment: Ruxolitinib · No Placebo Group · Phase 2

Paclitaxel (12weeks)Experimental Group · 4 Interventions: Cyclophosphamide, Paclitaxel, Ruxolitinib, Doxorubicin · Intervention Types: Drug, Drug, Drug, Drug
Ruxolitinib with Paclitaxel (12weeks)Experimental Group · 4 Interventions: Cyclophosphamide, Paclitaxel, Ruxolitinib, Doxorubicin · Intervention Types: Drug, Drug, Drug, Drug
Ruxolitinib and Paclitaxel (12weeks)Experimental Group · 4 Interventions: Cyclophosphamide, Paclitaxel, Ruxolitinib, Doxorubicin · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Paclitaxel
FDA approved
Ruxolitinib
FDA approved
Doxorubicin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,016 Previous Clinical Trials
393,793 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
315 Previous Clinical Trials
46,547 Total Patients Enrolled
Filipa Lynce, MDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
32 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
AST/ALT ratio < 2.5 X institutional upper limit of normal.
Breast cancer patients with invasive breast cancer must have histologically confirmed invasive breast cancer.
You have a clinical diagnosis of IBC, involving an intact breast.