Preoperative Radiation for Early-stage Breast Cancer
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
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
53 (estimated)
Sponsor
University of Texas Southwestern Medical Center · Other
Who this trial is looking for
This trial is looking for women with early-stage breast cancer who have not had surgery or chemotherapy yet. Participants will receive preoperative radiation therapy and may undergo additional imaging tests.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman age 18 or older.
I have invasive breast cancer that is 3 cm or smaller.
I have not had surgery for my current breast cancer.
My tumor is not affecting the skin.
I have had a breast MRI or contrast-enhanced mammography.
I have a positive estrogen or progesterone receptor and negative Her2neu.
My tumor is visible on CT or MRI scans.
You may not be able to join if
I have multi-centric disease.
I have had prior radiation to the same breast.
My tumor is larger than 3 cm.
I am pregnant or breastfeeding.
I have had breast cancer in the past.
I have active lupus or scleroderma.
I cannot undergo an MRI or contrast-enhanced mammography.
I have a positive lymph node at the time of ultrasound.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
1\. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor
Trial Locations
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Status
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 t…
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
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