Precision Medicine in Action: Phase II Trial of Response... | NCT06444269

NCT06444269

Status Module

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiomics on MRI	Radiation	Through extracting and analyzing a large number of features from medical imaging, radiomics has shown promising results in treatment outcome prediction for many diseases including breast cancer (45-50). UTSW physics group has developed several new radiomic approaches and radiomic features, such as a multi-objective radiomics model(51) and a new radiomic "Shell" feature(52). As an exploratory end point for this trial, the investigators will explore the application radiomics using pre-treatment MRI, treatment parameters and clinical characteristics as input to predict pathological response of radiation therapy (XRT) based on pathology report of surgical tissues and local recurrence.
microbubble CEUS Contrast Enhanced Ultrasound (CEUS)	Drug	Microbubble Contrast non-FDA approved for route of administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Single fraction pre-operative radiation	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.	4 years

Secondary Outcomes

Measure	Description	Time Frame
Microbubble contrast	To evaluate the potential of microbubble contrast enhanced ultrasound (CEUS) as a non-operative alternative to sentinel lymph node mapping and biopsy in early-stage ER+ Breast Cancer patients undergoing pre -operative single fraction radiation. Assess concordance of preoperative and pre-radiation microbubble CEUS with SLN mapping and biopsy at time of partial mastectomy.	4 years

Eligibility Module

Eligibility 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

Name	Role	Phone	Extension	Email
Sarah Neufeld, MS	Contact	214-645-8525		sarah.hardee@utsouthwestern.edu
Basak Dogan, MD	Contact	214/645-3290		Dogan.Basak@utsouthwestern.edu

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases