Intra-Operative Radiation Therapy Immediately Following Resection of Early Stage Breast Cancer

Breast Conserving Therapy (BCT) is a standard treatment option for patients with stage I or
II breast cancer. Breast conserving therapy consists of surgical removal of the tumor with
negative margins, axillary lymph node dissection or sentinel node biopsy and radiation
therapy. Several studies have shown BCT to be comparable to mastectomy in terms of overall
and disease free survival for patients. The major advantage to BCT over mastectomy is breast
preservation and reduced psychological trauma to the patient. The major disadvantage to BCT
is prolonged time of treatment. The whole breast radiation portion of BCT can add 7 weeks to
the treatment time. This additional treatment time can be a detriment to women who
logistically may not be able to meet the demands of daily irradiation for 6-7 weeks. A new
form of treatment, breast brachytherapy, was developed to decrease the treatment time
required for breast irradiation. This treatment uses the Xoft Axxent system to administer
intra-operative breast brachytherapy in one treatment, at the time of lumpectomy in the
operating room.

This study has been designed to assess local recurrence, serious adverse events, adverse
events and their severity, and cosmesis following intra-operative radiation therapy (IORT)
using the Xoft Axxent System and balloon applicators. The study device is FDA cleared. The
purpose of this clinical study is to compile data on the treatment of patients using the Xoft
Axxent System for the delivery of radiation therapy in the intra-operative setting as part of
breast conserving therapy in women with resected, early stage breast cancer.

General Inclusion Criteria

1. Age > 45 years

2. Tumor with Tis, T1, T2 (≤ 3cm), N0, M0 - (AJC Classification)

3. Invasive ductal carcinoma and / or DCIS

Intra-operative Inclusion Criteria

1. Negative sentinel node assessment

2. Balloon surface to skin distance of at least 1-cm and adequate conformance via
Intra-operative ultrasound

Post procedure Inclusion Criteria 1. Negative microscopic surgical margins**

**If positive margins patient my undergo re-excision and/or additional radiation at the
treating physician's discretion but the patient will be excluded from the protocol data
analysis.

General Exclusion Criteria

1. Scleroderma, systemic sclerosis and active lupus

2. Participation in an investigational drug or device study

3. Previous ipsilateral radiation to the thorax or breast

Intra-operative Exclusion Criteria

1. Intra-operative positive sentinel lymph node biopsy

2. Inadequate conformance (greater than 10% of PTV encompassed by fluid or air on
physician assessment of intraOp ultrasound image)

3. Skin spacing less than 1-cm via intraOp ultrasound.

4. A cavity size that is not appropriate for a 40 -70 cc balloon.

5. Patient becomes unstable and physician determines patient is not a good candidate at
time of lumpectomy.