Preoperative treatment for early-stage ER+ breast cancer using advanced imaging techniques
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
PHASE2 · University of Texas Southwestern Medical Center · NCT06444269
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06444269 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. 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. For cohort 1, it is highly recommended those tumors are at least 1 cm. 2\. Tumor must not involve the overlying skin based on imaging evaluation and/or clinical exam 3. Age \>/= 18 years old and female 4. Greatest Tumor dimension is 3cm or less based on US. MRI measurements can be included only if performed BEFORE the biopsy 5. Tumor must be unifocal 6. The tumor must be visible on CT scan and/or preferably marked with clip(s) in tumor if not visible. At least one clip should be placed in or around tumor prior to enrollment 7. Patients must undergo an MRI for work up to aid in tumor delineation and to rule out additional foci of disease. If additional foci of disease are present, they need to have a negative biopsy to proceed with treatment. 8\. Clinically and radiographically node negative on ultrasound of the axilla or MRI on on initial workup prior to microbubble contrast assessment 9. Estrogen receptor positive or Progesterone receptor positive and Her2neu negative 10. Ability to understand and the willingness to sign a written informed consent. 11\. 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. 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 12\. 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: \- 1. Multi-centric disease 2. Prior Radiation to the involved breast 3. Tumor Size \>3cm 4. 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 5. Prior ipsilateral breast cancer 6. Patients with active lupus or scleroderma 7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gadolinium or other agents used in study. 8\. If patient has a positive lymph node at time of microbubble contrast enhanced ultrasound, they will be removed from the study. Only N0 patients to be treated on this study.
Where this trial is running
Dallas, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer