Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
Public ClinicalTrials.gov record NCT04959474. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04959474
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 80 participants
Conditions and interventions
Conditions
Interventions
- Best Practice Other
- Stereotactic Body Radiation Therapy Radiation
- Resection Procedure
- Sentinel Lymph Node Biopsy Procedure
- Dietary Intervention Other
- Questionnaire Administration Other
- Quality-of-Life Assessment Other
- Mammography Procedure
- Biospecimen Collection Procedure
Other · Radiation · Procedure
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 22, 2021
- Primary completion
- Oct 31, 2028
- Completion
- Oct 31, 2028
- Last update posted
- Jan 22, 2026
2021 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04959474, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 22, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04959474 live on ClinicalTrials.gov.