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

NCT04959474 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-23

No results posted yet for this study

Summary

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

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

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Nicole Simone, MD · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2028-11-01
Completion
2028-11-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04959474 on ClinicalTrials.gov