Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05491226
The ClinicalTrials.gov registry entry for NCT05491226 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Stephen Shiao, which has 3 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Breast Cancer
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.
-
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
RECRUITING · Phase 2
-
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
RECRUITING · Phase 2
-
Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
RECRUITING · Phase 2
-
Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial
RECRUITING · Phase 2
-
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
RECRUITING · Phase 2
-
Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial
RECRUITING · Phase 2
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.