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NCT03546686 · ClinicalTrials.gov registry record · Phase 2
Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 4
- Study locations
NCT03546686: Recruiting Phase 2 study of Breast Cancer, sponsored by University of Texas Southwestern Medical Center.
NCT03546686 is a Phase 2 study of Breast Cancer that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 80 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03546686, a Phase 2 study of Breast Cancer, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to determine the impact of pre-operative cryoablation, and immune checkpoint inhibition (ICI) on on 3-year Event Free Survival (EFS), in women with residual hormone receptor negative, HER2-negative ("triple negative") resectable breast cancer after taxane-based neoadjuvant chemotherapy.
Primary Outcome
* Time (in months) between randomization and first occurrence of progression of disease that precludes surgery * Time (in months) between randomization and first occurrence local or distant disease recurrence * Time (in months) between randomization and date of death attributable to any cause including breast cancer, non-breast cancer, or unknown cause
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Nivolumab
- DRUG Ipilimumab
- PROCEDURE Breast Surgery
- PROCEDURE Core Biopsy/Cryoablation
Study Locations (4)
California
- Cedars Sinai Medical Center - Los Angeles
Ohio
- Ohio State University Medical Center - Columbus
Oregon
- Providence Cancer Institute - Portland
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2019-11-12 |
| Est. Completion | 2028-06 |
| Phase | Phase 2 |
What NCT03546686 shows while recruiting
NCT03546686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03546686 reports a single indexed study location in California, Ohio, Oregon.
Frequently Asked Questions
What is clinical trial NCT03546686 about?
NCT03546686 is a clinical study titled "Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer". The purpose of this study is to determine the impact of pre-operative cryoablation, and immune checkpoint inhibition (ICI) on on 3-year Event Free Survival (EFS), in women with residual hormone receptor negative, HER2-negative ("triple negative") resectable breast cancer after taxane-based neoadjuva...
What is the current status of trial NCT03546686?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2019-11-12. Estimated completion is 2028-06.
What conditions does trial NCT03546686 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03546686?
The interventions under investigation include: Pembrolizumab (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG), Breast Surgery (PROCEDURE), Core Biopsy/Cryoablation (PROCEDURE).
Who is sponsoring clinical trial NCT03546686?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03546686 being conducted?
This trial has 4 study locations across California, Ohio, Oregon, Texas. 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.
Where NCT03546686's enrollment target sits among peer trials
80 649th of 1224 higher than 566 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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