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.
• 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
• 9\. Patients with invasive disease are required to have clinical axillary staging including axillary 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