Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer (EXIBT)

Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer

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: 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. 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 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.

Patients who have early stage breast cancer, and are candidate for intracavitary accelerated partial breast irradiation may be considered for this study.

Radiation therapy, APBI, Intracavitary APBI, Accelerated partial breast irradiation, Xoft procedure, Partial breast irradiation, Partial breast radiation therapy, Balloon brachytherapy, Electronic source radiation therapy

34 Gy administered over 10 fractions, twice a day times five days. The radiation therapy treatment will be complete upon the 5th day.

The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; six month, one year, two year, three year, four year, and five year.

Local-regional Breast Failure - Ipsilateral breast failure at five years, Including: Ipsilateral recurrence within the initially treated volume, Ipsilateral recurrence of cancer outside of the initially treated volume, and axillary nodal recurrence

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

Dickler A, Kirk MC, Seif N, Griem K, Dowlatshahi K, Francescatti D, Abrams RA. A dosimetric comparison of MammoSite high-dose-rate brachytherapy and Xoft Axxent electronic brachytherapy. Brachytherapy. 2007 Apr-Jun;6(2):164-8. doi: 10.1016/j.brachy.2007.01.005.

Smitt MC, Kirby R. Dose-volume characteristics of a 50-kV electronic brachytherapy source for intracavitary accelerated partial breast irradiation. Brachytherapy. 2007 Jul-Sep;6(3):207-11. doi: 10.1016/j.brachy.2007.03.002.