Patient Registry: Partial Breast Irradiation

Breast Cancer Clinical Trial

— PBI Registry  

Official title:

Patient Registry: A Study of the Use of Accelerated Partial Breast Irradiation to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01127971
• Other study ID #: L-04-147E
• Status: Terminated
• Phase: N/A
• First received: May 20, 2010
• Last updated: October 22, 2014
• Start date: February 2010
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 145
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	5 and 10-year local recurrence rates	No
Secondary	collection and analysis of data to evaluate and compare cosmetic outcome	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))	5 and 10-year	No