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Clinical trialNCT04959474RecruitingInterventional

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

SponsorThomas Jefferson UniversityEnrollment80Anatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage 1 Breast Cancer AJCC v8Anatomic Stage 2 Breast Cancer AJCC v8Anatomic Stage 3 Breast Cancer AJCC v8Breast Ductal Carcinoma in SituInvasive Breast Carcinoma+1 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Nicole Simone, MD

    Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, United States

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
23 Aug 2021
Primary completion
1 Nov 2028
Completion
1 Nov 2028
Last update posted
23 Jan 2026
Registered enrollment
80
Registry id
NCT04959474

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.