RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2021-08-23

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04959474

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * Karnofsky performance status (KPS) score 70 - 100 * Tumor size =\< 3.0 cm * Gross disease within the breast must be unifocal * 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	* 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 * 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

Inclusion Criteria

Exclusion 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
* Karnofsky performance status (KPS) score 70 - 100
* Tumor size =\< 3.0 cm
* Gross disease within the breast must be unifocal
* 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

* 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
* 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

Contacts and Locations

Study Contact

Nicole Simone, MD

CONTACT

215-955-8874

Nicole.Simone@jefferson.edu

Study Locations (Sites)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-23

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2021-08-23

Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

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