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Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
NCT04959474 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- RADIATION Stereotactic Body Radiation Therapy
- OTHER Best Practice
- OTHER Dietary Intervention
- PROCEDURE Resection
- PROCEDURE Sentinel Lymph Node Biopsy
Study Locations (1)
Pennsylvania
- Thomas Jefferson University Hospital — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-08-23 |
| Est. Completion | 2028-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04959474
The ClinicalTrials.gov registry entry for NCT04959474 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 324 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Stereotactic Body Radiation Therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04959474 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04959474 about?
NCT04959474 is a clinical study titled "Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer". 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...
What is the current status of trial NCT04959474?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2021-08-23. Estimated completion is 2028-11-01.
What conditions does trial NCT04959474 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Anatomic Stage 0 Breast Cancer AJCC v8, Breast Ductal Carcinoma in Situ, Anatomic Stage 1 Breast Cancer AJCC v8, Anatomic Stage 2 Breast Cancer AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04959474?
The interventions under investigation include: Stereotactic Body Radiation Therapy (RADIATION), Best Practice (OTHER), Dietary Intervention (OTHER), Resection (PROCEDURE), Sentinel Lymph Node Biopsy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04959474?
This trial is sponsored by Thomas Jefferson University, which has 324 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04959474 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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