Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
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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