Preoperative treatment for early-stage ER+ breast cancer using advanced imaging techniques
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
Run by University of Texas Southwestern Medical Center · NCT06444269 · Data updated 2026-11-12
This study is testing if a new way of using radiation therapy with advanced imaging can help people with early-stage ER+ breast cancer and see if it might replace the need for a certain type of surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 53 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | October 11, 2024 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2028 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT06444269 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with early-stage ER+ breast cancer tumors that are 3 cm or less and have not received prior surgery or chemotherapy.
✕Probably not a fit
Patients with larger tumors, multifocal disease, or those who have previously undergone surgery or chemotherapy for their breast cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the efficacy of preoperative radiation therapy combined with advanced imaging techniques, specifically microbubble contrast-enhanced ultrasound (CEUS), in patients with early-stage ER+ breast cancer. The study aims to assess the response of tumors to this treatment approach and explore the potential of CEUS as a non-operative alternative to sentinel lymph node biopsy. Participants will undergo MRI and other imaging evaluations to ensure accurate tumor assessment and treatment planning.
Why it matters
Potential benefit: If successful, this approach could lead to more effective preoperative treatment options and potentially reduce the need for invasive surgical procedures.
How similar studies have gone: Other studies have shown promise in using advanced imaging techniques for breast cancer treatment, but this specific combination of preoperative radiation and CEUS is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * 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. Multifocal disease may be included if the aggregate span of disease is 3 cm or less, subject to investigator evaluation and approval. * 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. Exclusion Criteria * 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. Healthy Volunteer Inclusion Criteria * Ability to understand and the willingness to sign a written informed consent. * Age \>/= 18 years old and female * Without current diagnosis of breast cancer Healthy Volunteer Exclusion Criteria * Contraindication ot MRI * Volunteers who are pregnant
Where it's running
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UT Southwestern Medical Center-Dallas
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Asal Rahimi, MD — University of Texas Southwestern Medical Center
- Study coordinator: Sarah Neufeld, MS
- Email: sarah.hardee@utsouthwestern.edu
- Phone: 214-645-8525
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.