Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06444269

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

Led by University of Texas Southwestern Medical Center · Updated on 2025-11-05

53

Participants Needed

1

Research Sites

194 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 years or older
  • Invasive epithelial breast cancer histology (ductal, medullary, lobular, papillary, mucinous, or tubular) with tumor size 3 cm or less
  • Tumor does not involve overlying skin based on imaging or clinical exam
  • Tumor is unifocal and visible on CT scan or marked with clips
  • Tumor size confirmed by ultrasound; MRI measurements allowed if done before biopsy
  • Clinically and radiographically node negative by ultrasound or MRI
  • Estrogen receptor positive or progesterone receptor positive and Her2neu negative
  • Ability and willingness to provide informed consent
  • Women of child-bearing potential agree to use effective contraception during radiation therapy
  • If prior biopsy clip placed in sentinel lymph node, additional biopsy and clip placement may be done per investigator discretion
  • MRI required to rule out additional disease foci; additional foci require negative biopsy
Not Eligible

You will not qualify if you...

  • Multi-centric breast disease
  • Prior radiation therapy to the involved breast
  • Tumor size greater than 3 cm
  • Pregnant or lactating women
  • Prior ipsilateral breast cancer
  • Active lupus or scleroderma
  • History of allergic reaction to gadolinium or similar agents used in the study
  • Positive lymph node found by microbubble contrast enhanced ultrasound

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UT Southwestern Medical Center-Dallas

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

S

Sarah Neufeld, MS

CONTACT

B

Basak Dogan, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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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 | DecenTrialz