Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy

Phase 2

• Conditions: Breast Cancer
• Interventions: Radiation: Breast Brachytherapy with Mammosite RTS; Radiation: Intensity Modulated Radiotherapy

• Registration Number: NCT01185145
• Lead Sponsor: Rocky Mountain Cancer Centers

Brief Summary

Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11
• Primary Completion: 2014-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

• Be a Tis, T1, N0, M0 AJC Classification
• Have negative surgical margins (> or = 2 mm) after final surgery
• Should have adequate skin spacing between balloon surface and surface the skin (> 7 mm)*
• Patients with infiltrating lobular histologies should have breast MRI scanning as part of the initial staging to verify localized T1, or Tis disease
• Multifocal findings (define as 2 or more breast quadrants) on MRI scanning should be further evaluated by ultrasound and, if necessary biopsy, to exclude multiquadrant disease.

Exclusion Criteria

• Be pregnant or breast-feeding
• Have collagen-vascular disease
• Inadequate surgical margins (< 2 mm)
• Patients with malignant/suspicious calcifications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mammosite	Breast Brachytherapy with Mammosite RTS	Accelerated Partial Breast Irradiation using Mammosite RTS
IMRT	Intensity Modulated Radiotherapy	Accelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy

Primary Outcome Measures

Name	Time	Method
Overall Survival	2-15 years
Ipsilateral breast failure	2-15 years
Disease free survival	2-15 years
Cause specific survival	2-15 years

Secondary Outcome Measures

Name	Time	Method
Serious Adverse device-related Events	2-5 years

Trial Locations

Locations (6)

Rocky Mountain Cancer Centers - Aurora; 🇺🇸 Aurora, Colorado, United States

Rocky Mountain Cancer Centers - Boulder; 🇺🇸 Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Littleton; 🇺🇸 Littleton, Colorado, United States

Rocky Mountain Cancer Centers - Midtown; 🇺🇸 Denver, Colorado, United States

Rocky Mountain Cancer Centers - Sky Ridge; 🇺🇸 Lone Tree, Colorado, United States

Rocky Mountain Cancer Centers - Thornton; 🇺🇸 Thornton, Colorado, United States