Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer

This study is looking at how a special type of radiation, called Stereotactic Body Radiation Therapy (SABR), works for early-stage breast cancer when given before surgery. SABR is a focused radiation treatment that delivers a strong dose to the tumor while protecting healthy tissue. Researchers want to see if adding a caloric restriction diet to SABR helps shrink the tumor more than SABR alone. They will measure the percentage reduction in tumor cells to see if the combination treatment is more effective. This trial is for individuals aged 40 and older with certain types of breast cancer, including those with a BMI of 21 or higher. If you have triple-negative breast cancer, you must be 50 or older to participate. The study aims to enroll 80 participants.

Study design: This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 80 participants to compare the effects of SABR with and without caloric restriction.
What's involved: Participants will undergo SABR, potentially a caloric restriction diet, and surgical procedures including resection and sentinel lymph node biopsy. The primary endpoint is measured between 4-16 weeks, depending on surgery date.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome, tumor cellularity reduction, is measured between 4-16 weeks after treatment, depending on the date of surgery.

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Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer

Recruiting

NAAges 40+InterventionalTreatment

Thomas Jefferson University

~80 participants

Updated 2026-01-23 on ClinicalTrials.gov

What's tested:Best PracticeStereotactic Body Radiation TherapyResectionSentinel Lymph Node BiopsyDietary InterventionQuestionnaire Administration

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Percent reduction in cellularity of breast tumor

Measured over 4-16 weeks, depending on the date of 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

Triple Negative Breast Carcinoma

Where it's being run

1 sites across 1 states

Pennsylvania1

Study leadership

Nicole Simone, MD · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Who to contact

Nicole Simone, MD

[email protected]

215-955-8874

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

• 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

Karnofsky performance status (KPS) score 70 - 100

Tumor size =\< 3.0 cm

Gross disease within the breast must be unifocal

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

Exclusion

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

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

What this trial measures

Percent reduction in cellularity of breast tumor4-16 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.

Trialytics