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NCT05491226 · ClinicalTrials.gov registry record · Phase 2
Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation
A Phase 2 study of Breast Cancer and TNBC - Triple-Negative Breast Cancer, sponsored by Stephen Shiao.
- Active
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT05491226: Active Phase 2 study of Breast Cancer and TNBC - Triple-Negative Breast Cancer, sponsored by Stephen Shiao.
NCT05491226 is a Phase 2 study of Breast Cancer and TNBC - Triple-Negative Breast Cancer that is active but no longer recruiting, run by Stephen Shiao. The registered enrollment target is 35 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05491226, a Phase 2 study of Breast Cancer and TNBC - Triple-Negative Breast Cancer, is active but no longer recruiting, sponsored by Stephen Shiao.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The proportion of patients with absence of invasive disease in the breast and lymph nodes at the time of SOC curative-intent treatment.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- RADIATION Radiation Therapy
- DRUG Axatilimab
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2023-11-17 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 2 |
What the registry record for NCT05491226 still lists
NCT05491226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05491226 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05491226 about?
NCT05491226 is a clinical study titled "Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation". 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 in...
What is the current status of trial NCT05491226?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2023-11-17. Estimated completion is 2026-12-01.
What conditions does trial NCT05491226 study?
This clinical trial studies the following conditions: Breast Cancer, TNBC - Triple-Negative Breast Cancer.
What interventions are being tested in trial NCT05491226?
The interventions under investigation include: Pembrolizumab (DRUG), Radiation Therapy (RADIATION), Axatilimab (DRUG).
Who is sponsoring clinical trial NCT05491226?
This trial is sponsored by Stephen Shiao, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05491226 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05491226's enrollment target sits among peer trials
35 922nd of 1224 higher than 298 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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