What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as Paclitaxel, Doxorubicin, and Cyclophosphamide, have several known side effects. Paclitaxel can cause neuropathy, hair loss, and myelosuppression. Doxorubicin is associated with cardiotoxicity, myelosuppression, and mucositis. Cyclophosphamide can lead to myelosuppression, hemorrhagic cystitis, and secondary malignancies. When combined with Ruxolitinib, additional side effects may include anemia, thrombocytopenia, and increased risk of infections due to its immunosuppressive effects.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer include a variety of targeted therapies and inhibitors. Notably, Palbociclib, Ribociclib, and Abemaciclib are CDK4/6 inhibitors approved for HR-positive, HER2-negative breast cancer. Additionally, PARP inhibitors like Olaparib and Talazoparib are approved for patients with BRCA-mutated breast cancer. While Ruxolitinib, a JAK1 and JAK2 inhibitor, is being studied for its potential in treating inflammatory breast cancer, it is not yet FDA-approved for this indication. These approvals highlight the trend towards targeted therapies in breast cancer treatment.

What other types of research exist?

Promising novel alternatives to Ruxolitinib for breast cancer patients in 2024 include: 1) CDK4/6 inhibitors (e.g., Palbociclib, Ribociclib, Abemaciclib) which are effective in hormone receptor-positive breast cancer. 2) PARP inhibitors (e.g., Olaparib, Talazoparib) for patients with BRCA mutations. 3) Immunotherapy agents such as Pembrolizumab for triple-negative breast cancer. 4) Antibody-drug conjugates like Trastuzumab Deruxtecan for HER2-positive breast cancer. These alternatives have shown promising results in recent clinical trials and offer targeted treatment options.

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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

No Placebo-Only Group

Summary

This trial is testing a new drug called Ruxolitinib combined with three other cancer drugs to treat Inflammatory Breast Cancer (IBC). It targets patients who may not respond well to typical treatments. Ruxolitinib works by blocking a pathway that cancer cells need to grow and helps other drugs be more effective. Ruxolitinib has been beneficial in the treatment of myelofibrosis.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Biologic Response To 7-Day Run-In Window Phase Treatment of Ruxolitinib Alone or Ruxolitinib Plus Paclitaxel

Secondary study objectives

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 more

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

Peripheral artery thrombosis

Vertigo

Acute pulmonary oedema

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1170

Paclitaxel

2011

Completed Phase 4

~5450

Doxorubicin

2012

Completed Phase 3

~8030

Cyclophosphamide

2010

Completed Phase 4

~2310

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include Paclitaxel, Doxorubicin, and Cyclophosphamide. Paclitaxel works by stabilizing microtubules, preventing cell division, and leading to cell death. Doxorubicin intercalates DNA, inhibiting topoisomerase II and generating free radicals that damage cellular components. Cyclophosphamide is an alkylating agent that cross-links DNA strands, hindering DNA replication and transcription. These mechanisms are crucial as they target rapidly dividing cancer cells, reducing tumor growth and spread, which is vital for improving patient outcomes. Ruxolitinib, a JAK1 and JAK2 inhibitor, is being studied for its potential to disrupt cancer cell signaling pathways, offering a novel approach to treatment.