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

Description

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, Invasive Breast Carcinoma, Triple Negative Breast Carcinoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Anatomic Stage 0 Breast Cancer AJCC v8
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 axillary staging including axillary ultrasound (US) that proves patient is clinically node negative
  • * Patient is not being considered for preoperative chemotherapy
  • * Must be English or Spanish speaking
  • * 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

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Thomas Jefferson University,

Study Record Dates

2026-01-01