SABR-CaRe in Early Stage Breast Cancer

  • STATUS
    Recruiting
  • End date
    Jan 1, 2026
  • participants needed
    80
  • sponsor
    Thomas Jefferson University
Updated on 6 May 2022
body mass index
cancer
breast cancer
invasive breast cancer
breast cancer staging
sentinel lymph node biopsy

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.

Details
Condition Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8, Anatomic Stage 1A Breast Cancer AJCC v8, Anatomic Stage 1B Breast Cancer AJCC v8, Anatomic Stage 2 Breast Cancer AJCC v8, Anatomic Stage 2A Breast Cancer AJCC v8, Anatomic Stage 2B Breast Cancer AJCC v8, Anatomic Stage 3 Breast Cancer AJCC v8, Anatomic Stage 3A Breast Cancer AJCC v8, Anatomic Stage 3B Breast Cancer AJCC v8, Anatomic Stage 3C Breast Cancer AJCC v8, Breast Ductal Carcinoma in Situ, Invasive Breast Carcinoma, Prognostic Stage 0 Breast Cancer AJCC v8, Prognostic Stage 1 Breast Cancer AJCC v8, Prognostic Stage 1A Breast Cancer AJCC v8, Prognostic Stage 1B Breast Cancer AJCC v8, Prognostic Stage 2 Breast Cancer AJCC v8, Prognostic Stage 2A Breast Cancer AJCC v8, Prognostic Stage 2B Breast Cancer AJCC v8, Prognostic Stage 3 Breast Cancer AJCC v8, Prognostic Stage 3A Breast Cancer AJCC v8, Prognostic Stage 3B Breast Cancer AJCC v8, Prognostic Stage 3C Breast Cancer AJCC v8, Triple Negative Breast Carcinoma
Treatment questionnaire administration, Dietary intervention, quality-of-life assessment, stereotactic body radiation therapy, sentinel lymph node biopsy, Best Practice, Resection
Clinical Study IdentifierNCT04959474
SponsorThomas Jefferson University
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Age >= 40 years at time of consent
Patients with triple negative breast cancer (TNBC) must be >= 50 years of age at time of consent
Karnofsky performance status (KPS) score 70 - 100
Tumor size =< 3.0 cm
Gross disease within the breast must be unifocal
Gross disease may be multifocal as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension =< 3 cm
Patients with invasive disease are required to have axillary staging including
axillary ultrasound (US) that proves patient is clinically node negative
Patient is not being considered for preoperative chemotherapy
Must be English or Spanish speaking

Exclusion Criteria

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
Patients with oligo-metastatic disease who are being treated with curative intent per the treating physician will not be excluded if all other eligibility criteria are met
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
Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign
Paget's disease of the nipple
Previous breast radiation on ipsilateral side
Any prior treatment with radiation therapy or chemotherapy for the current breast cancer diagnosis prior to registration
Patients with significant psychiatric illness that would preclude them from adhering to the protocol in the judgement of the treating clinician
BMI < 21 at the time of study enrollment
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