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Pre-operative IRX-2 for Breast Cancer

Phase 1

Waitlist Available

Led By David Page, MD

Research Sponsored by Providence Health & Services

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Availability of at least one tumor-bearing core specimen from the breast cancer diagnostic biopsy

Invasive breast cancer of any receptor subtype diagnosed by core-needle biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1-26

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment to see if it is safe and effective.

Who is the study for?

This trial is for adults over 18 with early stage breast cancer, who are planning to have surgery and chemotherapy. It's specifically for those with a certain type of aggressive breast cancer (triple-negative) and tumors larger than 5 mm. Participants need to be in good health overall, as shown by their Karnofsky Performance status.

What is being tested?

The study tests the IRX-2 regimen's safety and how well patients respond before standard chemo. The regimen includes Cyclophosphamide, Indomethacin, Omeprazole, and Multivitamin given pre-operatively to see if it improves outcomes in triple-negative breast cancer cases.

What are the potential side effects?

Possible side effects from the IRX-2 regimen may include reactions related to immune system activation such as fever or fatigue; digestive issues due to Omeprazole; potential liver function changes from Indomethacin; and risks typically associated with Cyclophosphamide like hair loss or bladder irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a breast cancer biopsy sample available.

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My breast cancer was diagnosed with a needle biopsy.

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I am planning surgery or have triple-negative breast cancer for specific treatment.

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I am mostly able to care for myself and carry out daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1-26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1-26

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1-26 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Establish the Safety of the IRX-2 Regimen When Administered Pre-operatively in Early Stage Breast Cancer (ESBC) Patients

Secondary study objectives

Tumor Infiltrating Lymphocytes

Other study objectives

Characterization of Peripheral Lymphocytes

Intratumoral Immune Response

Intratumoral T-cell Clonality Response

+1 more

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401

88%

Pyrexia

65%

Neutrophil count decreased

62%

Nausea

58%

Hypotension

50%

Anaemia

46%

Headache

38%

Fatigue

38%

Decreased appetite

35%

Confusional state

31%

Tachycardia

31%

Diarrhoea

31%

Hypokalaemia

27%

Constipation

27%

Hypophosphataemia

27%

Back pain

23%

Dizziness

23%

Tremor

23%

B-cell lymphoma

23%

Platelet count decreased

23%

White blood cell count decreased

19%

Cough

19%

Agitation

19%

Hyponatraemia

19%

Neutropenia

19%

Tachypnoea

19%

Hypogammaglobulinaemia

19%

Oedema peripheral

15%

Hypomagnesaemia

15%

Thrombocytopenia

15%

Dysphagia

15%

Alanine aminotransferase increased

15%

Sinus tachycardia

15%

Chills

15%

Dyspnoea

12%

Aspartate aminotransferase increased

12%

Pain

12%

Arthralgia

12%

Myalgia

12%

Hypertension

12%

Hyperglycaemia

12%

Hypoxia

12%

Vomiting

12%

Abdominal pain

12%

Peripheral sensory neuropathy

12%

Covid-19

12%

Malaise

Dysuria

Muscular weakness

Blood creatinine increased

Hyperhidrosis

Insomnia

Acute myeloid leukaemia

Encephalopathy

Sepsis

Pancytopenia

Eye pain

Urinary tract infection

Lymphocyte count decreased

Asthenia

Somnolence

Oral candidiasis

Pneumonia

Gait disturbance

Aphasia

Pleural effusion

Depression

Embolism

Syncope

Respiratory failure

Febrile neutropenia

Covid-19 pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Axicabtagene Ciloleucel and Rituximab Combination

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: IRX-2 Regimen -Triple Negative Breast CancerExperimental Treatment4 Interventions

Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.

Group II: IRX-2 Regimen -Early Stage Breast CancerExperimental Treatment4 Interventions

Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Indomethacin

2011

Completed Phase 4

~5790