Intraoperative Radiation Therapy in Early Stage Breast Cancer

Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer

Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and 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