Pre-operative IRX-2 for Breast Cancer

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Providence Health & Services

Must not be taking: Corticosteroids, Anticoagulants, Immunosuppressants, others

Disqualifiers: Immunodeficiency, Cardiovascular disease, Autoimmune, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

16 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on chronic anticoagulation (blood thinners) that can't be safely stopped for at least 2 days before starting the study treatment. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment IRX-2 for breast cancer?

IRX-2 has shown promise in increasing immune responses against tumors, as seen in a study with oral cancer patients where it helped increase tumor-fighting immune cells. This suggests it might also help the immune system fight breast cancer. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients with early stage breast cancer (ESBC) and to estimate the pathologic complete response rate to neoadjuvant anthracycline-based and non-platinum containing chemotherapy in patients with triple-negative breast cancer who have received the IRX-2 Regimen before chemotherapy.

Research Team

David Page, MD

Principal Investigator

Providence Health & Services

Eligibility Criteria

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.

Inclusion Criteria

My organ functions are within normal ranges as required.

I have a breast cancer biopsy sample available.

My breast cancer was diagnosed with a needle biopsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

IRX-2 Regimen

Participants receive a single dose of cyclophosphamide and daily oral medications, with subcutaneous injections of IRX-2 over a 10-day period

3 weeks

Multiple visits for injections and monitoring

Chemotherapy

Participants receive neoadjuvant anthracycline-based and non-platinum containing chemotherapy

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• IRX-2

Trial Overview 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.

Participant Groups

Group I: IRX-2 Regimen -Triple Negative Breast Cancer Experimental Treatment 4 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 Cancer Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

Providence Health & Services

Lead Sponsor

Trials

131

Recruited

827,000+

Brooklyn ImmunoTherapeutics, LLC

Industry Sponsor

Trials

8

Recruited

5,500+

Findings from Research

In a trial involving 67 breast cancer patients undergoing neo-adjuvant therapy, pre-operative chemotherapy showed low side effects, with 79% of patients experiencing no hair loss and 74% reporting no gastrointestinal issues, despite the use of five different cytotoxic agents.

Response rates to pre-operative chemotherapy included 4% complete remission and 38% partial remission, indicating that while the treatment was generally well-tolerated, the effectiveness varied, and the study aims to identify which patients would benefit most from subsequent post-operative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective randomized clinical trial: protoadjuvant chemotherapy vs. protoadjuvant radiotherapy in breast cancer stages T3/4, N+/-, M0. Rainer, H.[2007]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Phase Ib Study of Preoperative, Locoregional IRX-2 Cytokine Immunotherapy to Prime Immune Responses in Patients with Early-Stage Breast Cancer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Recurrence Score® Result Impacts Treatment Decisions in Hormone Receptor-Positive, HER2-Negative Patients with Early Breast Cancer in a Real-World Setting-Results of the IRMA Trial. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

HER2DX genomic test in HER2-positive/hormone receptor-positive breast cancer treated with neoadjuvant trastuzumab and pertuzumab: A correlative analysis from the PerELISA trial. [2022]

5. Austria pubmed.ncbi.nlm.nih.gov

Prospective randomized clinical trial: protoadjuvant chemotherapy vs. protoadjuvant radiotherapy in breast cancer stages T3/4, N+/-, M0. [2007]