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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety of a new treatment called IRX-2 for individuals with early-stage and triple-negative breast cancer. The study aims to assess patient response to chemotherapy following the IRX-2 treatment. Participants will take a combination of medications and receive injections over several weeks before their regular cancer treatment. This trial may suit someone with a confirmed breast cancer diagnosis who plans to undergo surgery and has not yet begun any cancer treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the IRX-2 treatment is safe for patients with early-stage and triple-negative breast cancer. In past studies, patients tolerated the treatment well, and no serious safety issues emerged. For early-stage breast cancer, studies demonstrated that IRX-2 led to positive changes in the immune system, which is encouraging. In triple-negative breast cancer, the treatment was also well tolerated, supporting further research. Although this trial remains in the early stages and safety tests continue, the current data is promising regarding its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for breast cancer, which often include chemotherapy, radiation, or surgery, IRX-2 stands out due to its immunotherapy approach. This treatment uses a combination of a subcutaneous IRX-2 injection, which is believed to stimulate the immune system to fight cancer cells, along with supportive medications like cyclophosphamide, indomethacin, omeprazole, and zinc. Researchers are excited because IRX-2 directly targets the immune system, potentially offering a more targeted and less toxic alternative to conventional therapies. This approach could lead to improved outcomes for patients, especially those with triple-negative and early-stage breast cancer, where treatment options are currently limited.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that IRX-2, which participants in this trial may receive, may effectively treat triple-negative breast cancer. One study found that 83% of patients had a complete response with IRX-2, compared to 33% with another treatment. This suggests that IRX-2 might enhance the body's ability to fight cancer. For early-stage breast cancer, IRX-2 serves as another treatment option in this trial, proving safe and capable of positively affecting the immune system. Although the complete remission rate was low, patients tolerated the treatment well. Overall, these findings support further research into the effectiveness of IRX-2. ^{6 7 8 9 10}

Who Is on the Research Team?

David Page, MD

Principal Investigator

Providence Health & Services

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. aacrjournals.org aacrjournals.org/clincancerres/article/26/7/1595/83166/A-Phase-Ib-Study-of-Preoperative-Locoregional-IRX

A Phase Ib Study of Preoperative, Locoregional IRX-2 ... IRX-2 is safe in early-stage breast cancer. Potentially favorable immunomodulatory changes were observed, supporting further study of IRX-2 in early-stage ...

2. withpower.com withpower.com/trial/phase-1-breast-neoplasms-1-2017-8c006

Pre-operative IRX-2 for Breast Cancer · Info for Participants Response rates to pre-operative chemotherapy included 4% complete remission and 38% partial remission, indicating that while the treatment was generally well- ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1368837524001842

Phase Ib trial of IRX-2 plus durvalumab in patients with ... Median overall survival and progression-free survival (PFS) were 6.18 months (95 % CI, 2.66–8.61) and 2.53 months (95 % CI, 1.81–4.04), respectively. One ...

4. aacrjournals.org aacrjournals.org/cancerres/article/79/4_Supplement/P2-09-12/639327/Abstract-P2-09-12-Perilymphatic-IRX-2-cytokine

Abstract P2-09-12: Perilymphatic IRX-2 cytokine therapy to ... Conclusions: IRX-2 was well tolerated with preliminary evidence of sTIL increase, PD-L1 upregulation, and peripheral lymphocyte activation.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9858412/

Radiation in Early-Stage Breast Cancer: Moving beyond an ... We review existing data for radiotherapy omission, including the use of age, tumor subtype, and multigene profiling assays for selecting low-risk patients.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31831558/

A Phase Ib Study of Preoperative, Locoregional IRX-2 ... Conclusions: IRX-2 is safe in early-stage breast cancer. Potentially favorable immunomodulatory changes were observed, supporting further ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02950259

Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC) 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 ...

8. clients.adaptivebiotech.com clients.adaptivebiotech.com/pub/page-2019-ccr

A phase Ib study of preoperative, locoregional IRX-2 ... Conclusion: IRX-2 is safe in early stage breast cancer. Potentially favorable immunomodulatory changes were observed, supporting further ...

9. aacrjournals.org aacrjournals.org/clincancerres/article-abstract/26/7/1595/83166

A Phase Ib Study of Preoperative, Locoregional IRX-2 ... Conclusions: IRX-2 is safe in early-stage breast cancer. Potentially favorable immunomodulatory changes were observed, supporting further study of IRX-2 in ...

10. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.604

NeoIRX trial: Immunologic induction with peri-lymphatic ... Induction IRX-2 + pembro is well tolerated and is associated with encouraging outcomes, supporting further study of peri-lymphatic induction cytokine therapy.