Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy

Study Overview
=================
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.

Official Title
-----------------
A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: Breast Brachytherapy with Mammosite RTS
* Radiation: Intensity Modulated Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mammosite<br>Accelerated Partial Breast Irradiation using Mammosite RTS | Radiation: Breast Brachytherapy with Mammosite RTS<br>* Treatment will be performed using high dose rate brachytherapy, starting between 2-5 days of implant, 34 Gy at 1 cm in 3.4 Gy fractions BID for 5 treatment days with typical boost dose od 10 Gy given in 2 fractions at least 6 hours apart.<br>* Other names: APBI;|
| Experimental: IMRT<br>Accelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy | Radiation: Intensity Modulated Radiotherapy<br>* Accelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation<br>* Other names: Accelerated Partial Breast Irradiation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 2-15 years | 
| Disease free survival |  | 2-15 years | 
| Cause specific survival |  | 2-15 years | 
| Ipsilateral breast failure |  | 2-15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse device-related Events |  | 2-5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast-conservation, accelerated partial breast irradiation, APBI, IMRT, Intensity modulated radiotherapy, breast brachytherapy, lumpectomy, early stage breast cancer, DCIS, Mammosite