MedPath

Multi-catheter High Dose Rate (HDR) Breast Brachytherapy

Phase 2
Terminated
Conditions
Breast Cancer
Interventions
Radiation: brachytherapy
Registration Number
NCT00214149
Lead Sponsor
University of Wisconsin, Madison
Brief Summary

Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
127
Inclusion Criteria
  • Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is < 3 cm, N0 or N1 if 1-3 + nodes with no extracapsular extension
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1brachytherapybreast brachytherapy to a dose of 34 Gy
Primary Outcome Measures
NameTimeMethod
To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT5 years
Secondary Outcome Measures
NameTimeMethod
To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years3 years

Trial Locations

Locations (1)

University of Wisconsin Hospital and Clinics

🇺🇸

Madison, Wisconsin, United States

© Copyright 2025. All Rights Reserved by MedPath