NCT05491226

Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

IIT2021-01-Shiao-CSF1Ri: Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Stephen Shiao · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label prospective, single institution, Phase II study of pembrolizumab in combination with radiation therapy and CSF-1R inhibition in patients with high-risk TNBC. The primary objective is to assess the pathologic complete response (pCR) rate where pCR is defined as the absence of invasive disease in the breast and lymph nodes at the time of standard of care (SOC) treatment. Secondary objectives include evaluating the change in tumor infiltrating lymphocytes (TILs), safety and tolerability of the combination, progression-free survival, event-free survival, overall survival, and node clearance.

Conditions

• TNBC - Triple-Negative Breast Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200 mg is administered intravenously at Week 1, then every 3 weeks during the treatment period (6 weeks). Therapy will continue for until initiation of SOC curative-intent treatment (neoadjuvant chemo therapy or surgery) at Week 7.
RADIATION	Radiation Therapy	Radiation therapy (RT) consists of 8 Gy for 3 fractions over 3 consecutive days at Week 2.
DRUG	Axatilimab	Axatilimab 1 mg/kg is administered intravenously weekly starting 1 week post- RT (Week 3). Therapy will continue until initiation of SOC curative-intent treatment (neoadjuvant chemo therapy or surgery) at Week 7.

Timeline

• Start date: 2023-11-17
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-08-08
• Last updated: 2025-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study