PRINCIPAL INVESTIGATORS

• Rakesh Patel, MD- Radiation Oncologist
• Peter Beitsch, MD- Breast Surgeon

REGISTRY DESIGN

• Multicenter, non-randomized, post market registry of intracavitary accelerated partial breast irradiation in appropriately selected patients.

SAMPLE SIZE AND SITES:

• Approximately 400 patients may be enrolled.
• Up to 100 qualified U.S. sites may participate in this registry.

ENDPOINTS:

1. PRIMARY ENDPOINTS

   • Subcutaneous Toxicities - The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; at six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
   • Skin Toxicities - Specific toxicities that can result from radiation therapy will be recorded at each follow-up visit. The Common Terminology Criteria for Adverse Events will be used and to be recorded at each follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
   • Cosmetic Outcome - Cosmetic outcome will be recorded at the following follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. Cosmetic outcome will be assessed and graded in two ways:
   • Patient Quality of Life Questionnaire - A Quality of Life Questionnaire (QOL) will be completed at the following visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.

2. SECONDARY ENDPOINTS

   • Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral breast failure at five (5) years.

   This includes:

   • Ipsilateral recurrence within the initially treated volume. (Within the tumor bed)

   • Ipsilateral recurrence of cancer outside of the initially treated volume. (Elsewhere Failure)

   • Axillary nodal recurrence

     • Survival - to be recorded at each follow-up visit

   • Overall Survival

   • Disease Free Survival

     • Device Performance - to be recorded during the balloon applicator placement and during the course of the radiation treatments:

   • Ability to deliver treatment

   • Axxent System / Balloon Applicator performance

3. TREATMENT DEVICE

The device to be used is the electronic brachytherapy system for the treatment of early stage breast cancer with intracavitary accelerated partial breast irradiation. The device manufacturer is Xoft, Incorporated. All Xoft technology cleared by the FDA for the treatment of early stage breast cancer can be used in this post market data collection registry.

OVERSIGHT COMMITTEE

Representatives from American Brachytherapy Society (ABS), American Society of Breast Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study management.

Inclusion Criteria:

• Patient 50 years of age or older
• Estrogen receptor positive
• Tumor size ≤ 3cm
• Tumor histology: invasive carcinoma or DCIS
• Patient is node negative
• Patient has negative surgical margins (NSABP definition, no tumor on ink) after final surgery
• Life expectancy > 5 years

Exclusion Criteria:

• Pregnancy or breast-feeding. (If appropriate, patient must use birth control during the registry.) The need for a pregnancy test is based on the physician's standard practice and will be performed according to the physician's standard of care.
• Collagen Vascular Disease
• Scleroderma
• Systemic sclerosis
• Active lupus
• Infiltrating lobular histology
• Previous ipsilateral radiation to the thorax or breast