Patient Registry: Partial Breast Irradiation

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01127971

Acronym

PBI Registry

Enrollment

145

Registered

2010-05-21

Start date

2010-02-28

Completion date

2013-09-30

Last updated

2024-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

patients, receiving, irradiation, device, External Beam

Brief summary

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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))

Countries

United States

Outcome results