NCT04959474 · Thomas Jefferson University
Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
What this study is about
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.
View original scientific 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.
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
Primary outcome measures
Percent reduction in cellularity of breast tumor
Time frame: 4-16 weeks, depending on the date of surgery
The mean percent reduction will be compared between the study arms using a two-sample two-sided t-test with alpha 0.05.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 clinical axillary staging including axillary ultrasound (US) that proves patient is clinically node negative or can be done by physical examination if the patient is over 70
- 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
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 23, 2026 · Source of record for eligibility and locations