Back to search results

RAPS Trial: Early-Stage ER+ Breast Cancer Study

This study, called the RAPS Trial, is for women with early-stage ER+ (estrogen receptor positive) breast cancer that is 3 cm (centimeters) or less and has not been treated with surgery, hormone therapy, or chemotherapy. It is testing a new approach to treatment that involves a single dose of radiation before surgery. Researchers are also exploring if a special ultrasound using microbubble CEUS (Contrast Enhanced Ultrasound) can be used instead of a sentinel lymph node biopsy (a surgical procedure to check if cancer has spread to lymph nodes). The study will also look at how well the radiation treatment works on the tumor. Success will be measured by how well this single dose of radiation works over 4 years. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 53 women. It is a Phase II trial.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 4 years to measure the effectiveness of the pre-operative radiation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~53 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Radiomics on MRImicrobubble CEUS Contrast Enhanced Ultrasound (CEUS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Single fraction pre-operative radiation
Measured over 4 years

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Asal Rahimi, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Sarah Neufeld, MS
[email protected]
214-645-8525
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Invasive epithelial (ductal, medullary, lobular, papillary, mucinous (colloid), or tubular) histologies of the breast 3 cm or less(T1-T2cN0) in women who have not undergone surgery or neoadjuvant endocrine or chemotherapy for current breast cancer diagnosis. It is recommended that these tumors are at least 1 cm for cohort 1 and less than 1 cm for cohort 2, however this is not required.
Tumor must not involve the overlying skin based on imaging evaluation and/or clinical exam
Age \>/= 18 years old and female
If the tumor is unifocal, greatest tumor dimension is 3cm or less based on imaging.
The tumor must be visible on CTor MRI scan or preferably marked with clip(s) in tumor if not visible.
Patients must have undergone standard of care breast MRI or contrast-enhanced mammography for work up to aid in tumor delineation and to rule out multicentric disease. If areas suspicious of multicentric disease are seen which are beyond the scope of SBRT, they need to have a negative biopsy to proceed with treatment.
Clinically and radiographically node negative on ultrasound of the axilla or MRI on initial workup prior to microbubble contrast assessment (for cohort 1).
Estrogen receptor positive or Progesterone receptor positive and Her2neu negative Ability to understand and the willingness to sign a written informed consent. 10. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to the start of study and for the duration of radiation therapy as well as the endocrine therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months
For Cohort 1: If patient has had a prior biopsy clip placed in the lymph node deemed the sentinel lymph node at time of microbubble CEUS, it is up to investigator if additional biopsy and clip placement will be obtained.
Ability to understand and the willingness to sign a written informed consent.
Age \>/= 18 years old and female
Without current diagnosis of breast cancer

Exclusion

Multi-centric disease
Prior Radiation to the involved breast
Aggregate or single tumor Size \>3cm
Patients who are pregnant or lactating due to the potential exposure to the fetus to radiation therapy and unknown effects of radiation therapy to lactating females
Prior ipsilateral breast cancer
Patients with active lupus or scleroderma
Patients unable to have MRI or contrast-enhanced mammography per physician assessment.
For Cohort 1: If patient has a positive lymph node at time of microbubble contrast enhanced ultrasound, they will be removed from the study. Only cN0 patients to be treated on this study.
Contraindication ot MRI
Volunteers who are pregnant

What this trial measures

  • Single fraction pre-operative radiation4 years

    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 disease surgery will be postponed to 12-15 months.