NCT02685332

Phase I Dose Escalation of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation Early Stage Breast CA

Phase I Dose Escalation Trial of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation (SB-PBI) For Early Stage Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Radiation, Stereotactic Body Radiation Therapy.

Detailed description

In this protocol, we plan to use the uniqueness of the Cyberknife system to deliver an adjuvant single fraction radiation dose. We anticipate that this radiation deliver system will reduce toxicity and improve cosmesis. Extrapolating from an intra-operative body of work, this Phase I study will attempt to achieve a non-invasive low toxicity profile and maintain good to excellent cosmesis. In this effort, the Cyberknife system will be used to achieve high conformality and dose gradient.

Conditions

• Early Stage Breast Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiation	Stereotactic Body Partial Breast irradiation Step No. Fractions Dose per fraction -1 1 20 0 (starting) 1 22.5 1. 1 26.5 2. 1 30

Timeline

• Start date: 2016-03-31
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2016-02-18
• Last updated: 2025-07-20

Locations

2 sites across 1 country: United States