Pre-operative 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…
Conditions studied
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
About this study
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.
Interventions
- Other: Best Practice — Given standard dietary recommendations
- Radiation: Stereotactic Body Radiation Therapy — Undergo SABR
- Procedure: Resection — Undergo surgical resection
- Procedure: Sentinel Lymph Node Biopsy — Undergo sentinel lymph node biopsy
- Other: Dietary Intervention — Undergo a caloric restriction diet
- Other: Questionnaire Administration — Ancillary studies
- Other: Quality-of-Life Assessment — Ancillary studies
- Procedure: Mammography — Undergo mammography
- Procedure: Biospecimen Collection — Undergo blood, tissue, and rectal swab sample collection
Primary outcomes
- Percent reduction in cellularity of breast tumor (4-16 weeks, depending on the date of surgery)
Eligibility information
Study locations
- Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107 United States
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.