NCT04959474Recruiting
Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 27 Apr 2021
- Start date
- 23 Aug 2021
- Primary completion date
- 1 Nov 2028
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT04959474
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 23 Aug 2021 to the primary completion date, 1 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Previous breast radiation on ipsilateral side
- Any prior treatment with radiation therapy or chemotherapy for the current breast cancer diagnosis prior to registration
Other illness
- Paget's disease of the nipple
- Patients with significant psychiatric illness that would preclude them from adhering to the protocol in the judgement of the treating clinician
Other
- Patient is clinically node positive: clinically suspicious axillary lymph node(s) by axillary US or exam unless biopsied and found to be negative
- 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
- BMI \< 21 at the time of study enrollment
Who the study is looking for
- • 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.