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ACTIVE NOT RECRUITING Phase 2

Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen

NCT05591547 · View on ClinicalTrials.gov ↗

Study Summary

This study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. The standard external beam-based APBI treatment delivers treatments every other day for five treatments, over ten calendar days. The APBI in this study is modified and will deliver five once daily treatments over consecutive treatment days, with a slightly lower dose of radiation each day as compared to the standard external beam-based APBI treatment.

Conditions Studied

Interventions

  • RADIATION IMRT/VMAT-Based Accelerated Partial Breast Irradiation

Study Locations (2)

Minnesota

  • Sanford Health — Worthington

South Dakota

  • Sanford Health — Sioux Falls

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2022-03-30
Est. Completion 2027-06
Phase Phase 2

Sponsor

Sanford Health

78 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05591547

The ClinicalTrials.gov registry entry for NCT05591547 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanford Health, which has 78 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention — of which IMRT/VMAT-Based Accelerated Partial Breast Irradiation 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: NCT05591547 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Minnesota, South Dakota. 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 NCT05591547 about?

NCT05591547 is a clinical study titled "Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen". This study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. The standard external beam-based APBI treatment delivers treatments every other day...

What is the current status of trial NCT05591547?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2022-03-30. Estimated completion is 2027-06.

What conditions does trial NCT05591547 study?

This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05591547?

The interventions under investigation include: IMRT/VMAT-Based Accelerated Partial Breast Irradiation (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05591547?

This trial is sponsored by Sanford Health, which has 78 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05591547 being conducted?

This trial has 2 study locations across Minnesota, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial