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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorThomas Jefferson University

About this trial

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.

Eligibility criteria

Qualifiers

• 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

Disqualifiers

Patient is clinically node positive: clinically suspicious axillary lymph node(s) by axillary US or exam unless biopsied and found to be negative

Patient has stage IV metastatic disease

Breast tumor size is > 3.0 cm

Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor

Trial design

Treatments tested in this trial

  • Best Practice
  • Stereotactic Body Radiation Therapy
  • Resection
  • Sentinel Lymph Node Biopsy
  • Dietary Intervention
  • Questionnaire Administration
  • Quality-of-Life Assessment
  • Mammography
  • Biospecimen Collection

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators