Intraoperative Radiation Therapy in Early Stage Breast Cancer

The purpose of this clinical study is to assess the effectiveness of IORT, using an
electronic brachytherapy system, in patients with limited-volume in situ and early stage
breast cancer, with endpoints of:

- Local recurrence in early stage breast cancer patients treated with IORT.

- Toxicity associated with IORT.

- Long-term disease-specific and overall survival

- Cosmetic results using the Harvard Scale at start and follow-up periods in patients
treated with IORT.

- Quality of life in patients treated with IORT.

- Health care costs associated with IORT.

Inclusion Criteria:

General Inclusion Criteria

1. Age ≥ 45 years.

2. Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification).

3. Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in
situ.

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.

4. Multifocal breast cancer.

5. Pregnant patients.

6. Patient not competent to provide informed consent.

7. Neoadjuvant systemic therapy.

8. Lymphovascular invasion on biopsy pathology