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New treatment option for Breast Cancer
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
ClinicalTrials.gov ID: NCT06444269
What this study is testing
What is microbubble CEUS Contrast Enhanced Ultrasound (CEUS)?
microbubble CEUS Contrast Enhanced Ultrasound (CEUS) is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 1\. Efficacy of PULSAR preoperative radiation 2.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Invasive epithelial (ductal, medullary, lobular, papillary, mucinous (colloid), or tubular) histologies of the breast 3 cm or less(T1-T2cN0) in women...
- 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...
- The tumor must be visible on CTor MRI scan or preferably marked with clip(s) in tumor if not visible.
You likely can't join if
- 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...
- Prior ipsilateral breast cancer
- Patients with active lupus or scleroderma
See the full eligibility 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...
- 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...
- 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.