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NCT06444269 · ClinicalTrials.gov registry record · 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

A Phase 2 study of Breast Cancer, sponsored by University of Texas Southwestern Medical Center.

Recruiting
Registry status
Phase 2
Development phase
53
Enrollment target
1
Study location

NCT06444269: Recruiting Phase 2 study of Breast Cancer, sponsored by University of Texas Southwestern Medical Center.

NCT06444269 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 53 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06444269, 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
53 participants
Enrollment target
1
Study location

Study Summary

1\. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor

Primary Outcome

To determine efficacy of single fraction 30 Gy pre-operative radiation in early-stage ER+ breast cancer patients and determine pathologic complete response rate at 10-15 months after radiation. Patients that have not had a complete imaging response on MRI, OA, or on needle biopsy at 9 months will move onto a second fraction of PULSAR radiation of 8 Gy at 9-10 months. Surgery will be at 10-12 months for those with complete imaging response and negative needle biopsy. For those with residual disea

Conditions Studied

Interventions

  • RADIATION Radiomics on MRI
  • DRUG microbubble CEUS Contrast Enhanced Ultrasound (CEUS)

Study Locations (1)

Texas

  • UT Southwestern Medical Center-Dallas - Dallas

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2024-10-11
Est. Completion 2028-07-01
Phase Phase 2

What NCT06444269 shows while recruiting

NCT06444269 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Radiomics on MRI is the first listed.

NCT06444269 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06444269 about?

NCT06444269 is a clinical study titled "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". 1\. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor

What is the current status of trial NCT06444269?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2024-10-11. Estimated completion is 2028-07-01.

What conditions does trial NCT06444269 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT06444269?

The interventions under investigation include: Radiomics on MRI (RADIATION), microbubble CEUS Contrast Enhanced Ultrasound (CEUS) (DRUG).

Who is sponsoring clinical trial NCT06444269?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06444269 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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 NCT06444269's enrollment target sits among peer trials

53 775th of 1224 higher than 447 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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Source: ClinicalTrials.gov NCT06444269, the US trial registry maintained by the National Library of Medicine. NCT06444269 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.