Patient Registry: Partial Breast Irradiation

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT01127971
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This is an Aurora Health Care system registry of patients receiving accelerated partial breast irradiation and external beam.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-20
• Study First Posted: 2010-05-21
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• Aurora patients who decide to undergo PBI treatment in the next 5-years or who have had PBI Treatment in the last ten-years. All such patients are female.

Exclusion Criteria

• Patients not seen in an Aurora facility

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates is collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates	5 and 10-year local recurrence rates	The primary endpoint of this registry trial is collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates for each PBI type used and for the overall Aurora population. The following endpoints will also be reported and analyzed: * Disease Free Survival; * Regional Recurrence; * Distant Metastasis; * Combined Recurrence

Secondary Outcome Measures

Name	Time	Method
collection and analysis of data to evaluate and compare cosmetic outcome	5 and 10-year	The secondary endpoint is the collection and analysis of data to evaluate and compare cosmetic outcome (per Harvard Score) and toxicities/complications for each PBI type (per Common Terminology Criteria for Adverse Events (referred to as CTC or CTCAE))

Trial Locations

Locations (1)

Aurora BayCare Medical Center; 🇺🇸 Green Bay, Wisconsin, United States