Multi-catheter High Dose Rate (HDR) Breast Brachytherapy

Phase 2TerminatedNCT00214149

University of Wisconsin, Madison127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

127

Conditions

Breast Cancer

Interventions

breast brachytherapy to 34 Gy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT

Time frame: 5 years

Secondary Outcomes

To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years

Time frame: 3 years

Data from ClinicalTrials.gov

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