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NCT05645380 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC
A Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by University of Kansas Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 139
- Enrollment target
- 7
- Study locations
NCT05645380: Recruiting Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by University of Kansas Medical Center.
NCT05645380 is a Phase 2 study of Breast Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by University of Kansas Medical Center. The registered enrollment target is 139 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05645380, a Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by University of Kansas Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 139 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer.
Primary Outcome
Defined as percentage of participants who achieve pathological complete response in the breast and axilla. Pathological complete response is defined as no evidence of invasive disease in the breast (residual DCIS permitted) and axilla at the time of pathology review.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cyclophosphamide
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Doxorubicin
Study Locations (7)
Kansas
- The University of Kansas Cancer Center - Clinical Research Center - Fairway
- The University of Kansas Cancer Center - Main Hospital - Kansas City
- The University of Kansas Cancer Center - Westwood - Kansas City
- The University of Kansas Cancer Center - Overland Park - Overland Park
Missouri
- The University of Kansas Cancer Center - North - Kansas City
- The University of Kansas Cancer Center - Lee's Summit - Lee's Summit
- University of Kansas Cancer Center at North Kansas City Hospital - North Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2022-12-05 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT05645380 shows while recruiting
NCT05645380 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05645380 lists 7 locations in 2 states (Kansas, Missouri).
Frequently Asked Questions
What is clinical trial NCT05645380 about?
NCT05645380 is a clinical study titled "Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC". This study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer.
What is the current status of trial NCT05645380?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2022-12-05. Estimated completion is 2026-12.
What conditions does trial NCT05645380 study?
This clinical trial studies the following conditions: Breast Cancer, Triple Negative Breast Cancer.
What interventions are being tested in trial NCT05645380?
The interventions under investigation include: Pembrolizumab (DRUG), Cyclophosphamide (DRUG), Carboplatin (DRUG), Docetaxel (DRUG), Doxorubicin (DRUG).
Who is sponsoring clinical trial NCT05645380?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05645380 being conducted?
This trial has 7 study locations across Kansas, Missouri. 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 NCT05645380's enrollment target sits among peer trials
139 469th of 1224 higher than 755 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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