Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer (NCT04959474)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Thomas Jefferson University Hospital — Philadelphia, Pennsylvania
Age range: 40 Years
🧪 Interventions in This Study
- Best Practice (OTHER)
- Stereotactic Body Radiation Therapy (RADIATION)
- Resection (PROCEDURE)
- Sentinel Lymph Node Biopsy (PROCEDURE)
- Dietary Intervention (OTHER)
- Questionnaire Administration (OTHER)
- Quality-of-Life Assessment (OTHER)
- Mammography (PROCEDURE)
- Biospecimen Collection (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania
📞 Contact the Study Coordinator
Phone: (215) 955-8874
Email: Nicole.Simone@jefferson.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.