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NCT04959474 · ClinicalTrials.gov registry record · NA
Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
A NA study of Invasive Breast Carcinoma and Triple-Negative Breast Carcinoma, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT04959474: Recruiting NA study of Invasive Breast Carcinoma and Triple-Negative Breast Carcinoma, sponsored by Thomas Jefferson University.
NCT04959474 is a NA study of Invasive Breast Carcinoma and Triple-Negative Breast Carcinoma that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 80 participants, below the 483-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04959474, a NA study of Invasive Breast Carcinoma and Triple-Negative Breast Carcinoma, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The mean percent reduction will be compared between the study arms using a two-sample two-sided t-test with alpha 0.05.
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 |
What NCT04959474 shows while recruiting
NCT04959474 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 483-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (83% lower).
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.
NCT04959474 reports a single indexed study location in Pennsylvania.
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, Triple-Negative Breast Carcinoma, Breast Ductal Carcinoma In Situ, Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8.
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).
Who is sponsoring clinical trial NCT04959474?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Invasive Breast Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04959474's enrollment target sits among peer trials
80 29th of 45 higher than 17 of 45 other Invasive Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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