SABR-CaRe in Early Stage Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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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

Intervention / Treatment
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* Other: Best Practice
* Radiation: Stereotactic Body Radiation Therapy
* Procedure: Sentinel Lymph Node Biopsy
* Other: Questionnaire Administration
* Other: Quality-of-Life Assessment
* Procedure: Resection
* Other: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (standard dietary recommendations, SABR, surgery)<br>Patients receive standard dietary recommendations. Patients undergo SABR every other day for 5 fractions. Within 4-12 weeks of completion of SABR, patients undergo surgical resection with sentinel lymph node biopsy. | Other: Best Practice<br>* Given standard dietary recommendations<br>Radiation: Stereotactic Body Radiation Therapy<br>* Undergo SABR<br>Procedure: Sentinel Lymph Node Biopsy<br>* Undergo sentinel lymph node biopsy<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>|
| Experimental: Arm II (caloric restriction diet, SABR, surgery)<br>Beginning 1 week before the start of SABR, patients undergo a caloric restriction diet for 6-12 weeks (for the duration of radiation treatment, until post radiation follow-up appointment) consisting of reducing calorie intake by 25%. Patients undergo SABR every other day for 5 fractions. Within 4-12 weeks of completion of SABR, patients undergo surgical resection with sentinel lymph node biopsy. | Radiation: Stereotactic Body Radiation Therapy<br>* Undergo SABR<br>Procedure: Sentinel Lymph Node Biopsy<br>* Undergo sentinel lymph node biopsy<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>Procedure: Resection<br>* Undergo surgical resection<br>Other: Dietary Intervention<br>* Undergo a caloric restriction diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in cellularity of breast tumor | The mean percent reduction will be compared between the study arms using a two-sample two-sided t-test with alpha 0.05. | 4-12 weeks after biopsy |