An interventional study of Best Practice and Stereotactic Body Radiation Therapy in Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8 and Anatomic Stage 2 Breast Cancer AJCC v8, sponsored by Thomas Jefferson University. Recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Treatment
This phase II trial studies the effect of calorie reduction while undergoing stereotactic ablative radiation therapy in treating patients with breast cancer. Stereotactic ablative radiation therapy (sABR) is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organ. Giving SABR before surgery may make the tumor smaller. Adding dietary restrictions in combination with radiation therapy may help increase local control and decrease the spread of the cancer to other places in the body. The purpose of this trial is to identify if there is a decrease in tumor tissue in patients undergoing caloric restriction during pre-operative SABR, compared to patients undergoing pre-operative SABR alone.
PRIMARY OBJECTIVE:
I. To detect a decrease in cellularity of the tumor in participants undergoing caloric restriction during pre-operative SABR as compared to participants undergoing SABR alone.
SECONDARY OBJECTIVES:
I. Change in miR-21 as defined by baseline and post radiation levels. II. Investigate measurable changes of patient and tumor characteristics from the combination of SABR and caloric restriction (CR) versus SABR alone to inform future trials.
III. To describe pathologic complete response (pCR) rates as defined by no residual carcinoma or no residual invasive carcinoma, but ductal carcinoma in situ (DCIS) may be present, in each arm as well as by subtype.
IV. To assess response of each treatment arm using contrast-enhanced mammography (CEM) and correlate with pathologic response.
V. To describe short term surgical outcomes including: sentinel lymph node (SLN) identification rate, positive margins requiring return to the operative room for re-excision, and post-operative complications (infection, delayed wound healing, seroma requiring aspiration).
VI. To measure patient reported health-related outcomes and satisfaction with outcome.
VII. To compare patient reported cosmesis to physician reported cosmesis scores, where cosmesis is rated as excellent, good, fair or poor.
VIII. To compare pCR rates between women randomized to SABR alone to women randomized to SABR + CR who are at least 80% adherent to the CR intervention.
IX. To compare pCR rates between women randomized to SABR alone who do not deviate by more than 10% from their baseline caloric intake to women randomized to SABR + CR who are at least 80% adherent to the CR intervention.
EXPLORATORY OBJECTIVES:
I. Tissue: To determine the downstream molecular effects of diet related to miR-21 such as FAS/FASL, PD-1, LAG3 and STAT3 expression.
II. Microbiome: Compare baseline to post-SABR microbiome species separately for each trial arm.
III. Serum: Determine if anti-tumor immunity has increased with increased CD8 and decreased Treg in tumor. Compare proteomic profiles.
TERTIARY OBJECTIVE:
I. To determine the ipsilateral breast recurrence rate, distant disease-free interval, recurrence free survival, and overall survival.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard dietary recommendations. Patients undergo SABR every other day for 5 fractions. Within 4-12 weeks of completion of SABR, patients undergo surgical resection with sentinel lymph node biopsy.
ARM II: Beginning 1 week before the start of SABR, patients undergo a caloric restriction diet for 6-12 weeks (for the duration of radiation treatment, until post radiation follow-up appointment) consisting of reducing calorie intake by 25%. Patients undergo SABR every other day for 5 fractions. Within 4-12 weeks of completion of SABR, patients undergo surgical resection with sentinel lymph node biopsy.
After completion of study intervention, patients are followed up at 3-6 weeks, and then 6 months after surgery.
142 studies on the registry are indexed under Breast Carcinoma In Situ; 26 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 109 interventional studies indexed under Breast Carcinoma In Situ.
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Age >= 40 years at time of consent
* Patients with triple negative breast cancer (TNBC) must be >= 50 years of age at time of consent
Gross disease within the breast must be unifocal
* Gross disease may be multifocal as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension =\< 3 cm
Exclusion Criteria:
Patient has stage IV metastatic disease
* Patients with oligo-metastatic disease who are being treated with curative intent per the treating physician will not be excluded if all other eligibility criteria are met
Patients receive standard dietary recommendations. Patients undergo SABR every other day for 5 fractions. Within 4-12 weeks of completion of SABR, patients undergo surgical resection with sentinel lymph node biopsy.
Other: Best Practice · Radiation: Stereotactic Body Radiation Therapy · Procedure: Resection · Procedure: Sentinel Lymph Node Biopsy · Other: Questionnaire Administration · Other: Quality-of-Life Assessment · Procedure: Mammography · Procedure: Biospecimen Collection
Beginning 1 week before the start of SABR, patients undergo a caloric restriction diet for 6-12 weeks (for the duration of radiation treatment, until post radiation follow-up appointment) consisting of reducing calorie intake by 25%. Patients undergo SABR every other day for 5 fractions. Within 4-12 weeks of completion of SABR, patients undergo surgical resection with sentinel lymph node biopsy.
Radiation: Stereotactic Body Radiation Therapy · Procedure: Resection · Procedure: Sentinel Lymph Node Biopsy · Other: Dietary Intervention · Other: Questionnaire Administration · Other: Quality-of-Life Assessment · Procedure: Mammography · Procedure: Biospecimen Collection
Given standard dietary recommendations
Also known as: best practice, standard of care, standard of care, standard therapy
Undergo SABR
Also known as: SABR, SBRT, SBRT, Stereotactic Ablative Body Radiation Therapy, stereotactic body radiation therapy
Undergo surgical resection
Also known as: Resection, resection, Surgical Resection, SURGICAL RESECTION, Surgical Resection, Surgical Resection, Surgical Resection
Undergo sentinel lymph node biopsy
Also known as: SENTINEL LYMPH NODE BIOPSY, sentinel lymph node biopsy, Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Undergo a caloric restriction diet
Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Ancillary studies
Ancillary studies
Also known as: Quality of Life Assessment
Undergo mammography
Also known as: Mammography, MAMMOGRAPHY, mammography, MG
Undergo blood, tissue, and rectal swab sample collection
Also known as: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection
Percent reduction in cellularity of breast tumor
The mean percent reduction will be compared between the study arms using a two-sample two-sided t-test with alpha 0.05.
Time frame: 4-16 weeks, depending on the date of surgery
Feasibility of identifying sentinel lymph node (SLN)
Sentinel lymph node biopsy performed at the time of surgical resection per standard institutional protocol including dual tracer SLN identification. The first 10 enrolled patients who have a SLN biopsy performed (decided per institutional protocol and surgeon standard practice)will be assessed to determine the feasibility of identifying sentinel lymph node after pre-operative SABR and if the rate of SLN mapping is not at least 95% the trial will be closed to accrual and modified to reflect the safety and feasibility of finding the sentinel node.
Time frame: After pre-operative SABR
Global physiologic assessment
Weight, height, and body composition will be assessed. Calipers will be used to assess biceps, triceps, scapula, and hips. Bioimpedence will be used to measure percent body fat and muscle mass.
Time frame: Up to 6 months after SABR
Change in patient-reported health-related quality of life
Psycho-social evaluation will be done using the Patient Reported Outcomes Measurement Information System cancer fatigue short form, the National Comprehensive Cancer Network distress thermometer, and Functional Assessment of Cancer Therapy-Breast measure to determine how the interventions affect the patients prior to intervention, just before surgery, and end of treatment visit post SABR completion.
Time frame: Baseline to 6 months after SABR
Physician cosmesis evaluation
Physicians will evaluate cosmesis using the excellent, good, fair, poor scale at the times specified in the Study Schedule.
Time frame: Up to 6 months after SABR
Rate of positive margins and need for re-excision
Positive margin is defined as the presence of invasive carcinoma at the inked margin of the submitted operative specimen that does not appear to have significant radiation effect. The same definition will be applied to ductal carcinoma in situ (DCIS); however, there should be a 2mm margin on DCIS from the inked edge of the operative specimen. Will be compared between the study arms using a two-sample two-sided Fisher's exact with alpha 0.05.
Time frame: Up to 6 months after SABR
Rate of post-operative complications
The presence or absence of the following potential adverse effects will be assessed: infection/cellulitis requiring antibiotics, wound dehiscence or open wound, and persistent seroma requiring aspiration. Will be compared between the study arms using a two-sample two-sided Fisher's exact with alpha 0.05.
Time frame: Up to 6 months after SABR
Change in tumor stiffness, angiogenesis, and tumor size
Contrast-enhanced mammography and ultrasound shear-wave elastography will be done at baseline and just before surgical intervention to determine if diet improves tumor stiffness and angiogenesis as well as size of tumor. Will be compared between the study arms using a two-sample two-sided t-test with alpha 0.05.
Time frame: Baseline and before surgery
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