Recruiting

SABR with Caloric Restriction

Sponsor:

Thomas Jefferson University

Code:

NCT04959474

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

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Stereotactic Body Radiation Therapy

Resection

Sentinel Lymph Node Biopsy

Dietary Intervention

Study Details

Brief 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 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.

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

Study ID

NCT04959474

Start date

Aug 23, 2021

Status verified date

Jan, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (standard dietary recommendations, SABR, surgery)

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.

experimental: Arm II (caloric restriction diet, SABR, surgery)

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.

Interventions

Best Practice

Given standard dietary recommendations

Stereotactic Body Radiation Therapy

Undergo SABR

Resection

Undergo surgical resection

Sentinel Lymph Node Biopsy

Undergo sentinel lymph node biopsy

Dietary Intervention

Undergo a caloric restriction diet

Questionnaire Administration

Ancillary studies

Quality-of-Life Assessment

Ancillary studies

Mammography

Undergo mammography

Biospecimen Collection

Undergo blood, tissue, and rectal swab sample collection

Primary outcome measure

  • Percent reduction in cellularity of breast tumor [ Time Frame: 4-16 weeks, depending on the date of surgery ]

Central Contacts and Locations

Central contacts

Nicole Simone, MD

215-955-8874Nicole.Simone@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Nicole Simone, MD

215-955-6702Nicole.Simone@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-01-23.