Anatomic Stage 0 Breast Cancer AJCC v8NCT04959474
Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
A study testing Best Practice, Stereotactic Body Radiation Therapy and Resection in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage 1 Breast Cancer AJCC v8, run by Thomas Jefferson University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8, Anatomic Stage 2 Breast Cancer AJCC v8
- What is being tested?
- Best Practice, Stereotactic Body Radiation Therapy and Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients with pathologically proven DCIS or invasive breast cancer histologies
- Willing and able to provide informed consent
- Willing and able to comply with study treatments including dietary intervention
- Body mass index (BMI) >= 21 at time of enrollment
- Age >= 40 years at time of consent
- Patients with triple negative breast cancer (TNBC) must be >= 50 years of age at time of consent
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- Karnofsky performance status (KPS) score 70 - 100
- Tumor size =< 3.0 cm
- 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
- Patients with invasive disease are required to have clinical axillary staging including axillary ultrasound (US) that proves patient is clinically node negative or can be done by physical examination if the patient is over 70
- Patient is not being considered for preoperative chemotherapy
- Must be English or Spanish speaking
Who cannot join
- Patient is clinically node positive: clinically suspicious axillary lymph node(s) by axillary US or exam unless biopsied and found to be negative
- 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
- Breast tumor size is > 3.0 cm
- Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor
- Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign
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- Paget's disease of the nipple
- Previous breast radiation on ipsilateral side
- Any prior treatment with radiation therapy or chemotherapy for the current breast cancer diagnosis prior to registration
- Patients with significant psychiatric illness that would preclude them from adhering to the protocol in the judgement of the treating clinician
- BMI < 21 at the time of study enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Nicole Simone, MD, 215-955-6702, Nicole.Simone@jefferson.edu
About this study
Official title: SABR-CaRe: A Phase II Randomized Trial of Pre-Operative Stereotactic Ablative Radiation Therapy (SABR) With and Without Caloric Restriction for Early Stage Breast Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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:
- 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:
- 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.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8, Anatomic Stage 2 Breast Cancer AJCC v8, Anatomic Stage 3 Breast Cancer AJCC v8, Breast Ductal Carcinoma in Situ, Invasive Breast Carcinoma
- Being tested
- Best Practice, Stereotactic Body Radiation Therapy, Resection, Sentinel Lymph Node Biopsy, Dietary Intervention
- Medical subject headings
- Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called best practice, standard of care, standard of care, standard therapy
Given standard dietary recommendations
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, SBRT, Stereotactic Ablative Body Radiation Therapy, stereotactic body radiation therapy
Undergo SABR
ResectionProcedure or surgery
Also called Resection, resection, Surgical Resection, SURGICAL RESECTION, Surgical Resection, Surgical Resection, Surgical Resection
Undergo surgical resection
Sentinel Lymph Node BiopsyProcedure or surgery
Also called SENTINEL LYMPH NODE BIOPSY, sentinel lymph node biopsy, Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Undergo sentinel lymph node biopsy
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Undergo a caloric restriction diet
Questionnaire AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
MammographyProcedure or surgery
Also called Mammography, MAMMOGRAPHY, mammography, MG
Undergo mammography
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection
Undergo blood, tissue, and rectal swab sample collection
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard dietary recommendations, SABR, surgery) | Active comparator | 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. Receives: 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 |
| Arm II (caloric restriction diet, SABR, surgery) | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-16 weeks, depending on the date of surgery
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start23 Aug 2021
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage 0 Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Simone, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959474
- Sponsor's protocol ID
- 20D.876
- Other IDs
- JT 12711
- Status last verified
- Jan 2026
- First submitted
- 27 Apr 2021
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SABR-CaRe: A Phase II Randomized Trial of Pre-Operative Stereotactic Ablative Radiation Therapy (SABR) With and Without Caloric Restriction for Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT04959474
- Acronym / sponsor ID
- 20D.876
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8, Anatomic Stage 2 Breast Cancer AJCC v8, Anatomic Stage 3 Breast Cancer AJCC v8, Breast Ductal Carcinoma in Situ, Invasive Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard dietary recommendations, SABR, surgery) | Active comparator | 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 CollectionPatients 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 (caloric restriction diet, SABR, surgery) | Experimental | 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 CollectionBeginning 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- • Patients with pathologically proven DCIS or invasive breast cancer histologies
- Willing and able to provide informed consent
- Willing and able to comply with study treatments including dietary intervention
- Body mass index (BMI) >= 21 at time of enrollment
- Age >= 40 years at time of consent
Key exclusion criteria (11 listed)
- Patient is clinically node positive: clinically suspicious axillary lymph node(s) by axillary US or exam unless biopsied and found to be negative
- Patient has stage IV metastatic disease
- Breast tumor size is > 3.0 cm
- Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor
- Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: best practice, standard of care, standard of care, standard therapyGiven standard dietary recommendations | Other | Arm I (standard dietary recommendations, SABR, surgery) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, SBRT, Stereotactic Ablative Body Radiation Therapy, stereotactic body radiation therapyUndergo SABR | Radiation | Arm I (standard dietary recommendations, SABR, surgery), Arm II (caloric restriction diet, SABR, surgery) |
| ResectionAlso: Resection, resection, Surgical Resection, SURGICAL RESECTION, Surgical Resection, Surgical Resection, Surgical ResectionUndergo surgical resection | Procedure or surgery | Arm I (standard dietary recommendations, SABR, surgery), Arm II (caloric restriction diet, SABR, surgery) |
| Sentinel Lymph Node BiopsyAlso: SENTINEL LYMPH NODE BIOPSY, sentinel lymph node biopsy, Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNBUndergo sentinel lymph node biopsy | Procedure or surgery | Arm I (standard dietary recommendations, SABR, surgery), Arm II (caloric restriction diet, SABR, surgery) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional InterventionsUndergo a caloric restriction diet | Other | Arm II (caloric restriction diet, SABR, surgery) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (standard dietary recommendations, SABR, surgery), Arm II (caloric restriction diet, SABR, surgery) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (standard dietary recommendations, SABR, surgery), Arm II (caloric restriction diet, SABR, surgery) |
| MammographyAlso: Mammography, MAMMOGRAPHY, mammography, MGUndergo mammography | Procedure or surgery | Arm I (standard dietary recommendations, SABR, surgery), Arm II (caloric restriction diet, SABR, surgery) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen CollectionUndergo blood, tissue, and rectal swab sample collection | Procedure or surgery | Arm I (standard dietary recommendations, SABR, surgery), Arm II (caloric restriction diet, SABR, surgery) |
Primary outcome
Percent reduction in cellularity of breast tumor
Time frame: 4-16 weeks, depending on the date of surgery
The mean percent reduction will be compared between the study arms using a two-sample two-sided t-test with alpha 0.05.
7 secondary outcomes
Feasibility of identifying sentinel lymph node (SLN)
Time frame: After pre-operative SABR
Global physiologic assessment
Time frame: Up to 6 months after SABR
Change in patient-reported health-related quality of life
Time frame: Baseline to 6 months after SABR
Physician cosmesis evaluation
Time frame: Up to 6 months after SABR
Rate of positive margins and need for re-excision
Time frame: Up to 6 months after SABR
Rate of post-operative complications
Time frame: Up to 6 months after SABR
Change in tumor stiffness, angiogenesis, and tumor size
Time frame: Baseline and before surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Simone, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Stereotactic Body Radiation Therapy and Resection in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage 1 Breast Cancer AJCC v8, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Simone, MD (215-955-8874, Nicole.Simone@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in cellularity of breast tumor (time frame: 4-16 weeks, depending on the date of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.