Pre-operative IRX-2 for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byDavid Page, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Providence Health & Services

Stay on Your Current Meds

No Placebo Group

Trial Summary

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.

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.

+5 more

Participant Groups

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.

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.