A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast

A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast for Women With Stage 0, 1, or IIA (<=3cm) Breast Cancer

This pilot study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the CyberKnife in anticipation of a larger multi-institutional Phase II study. It will evaluate quality of life (QOL) issues as they relate to treatment related side effects, cosmetic result, and patient convenience.

Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and sentinel/axillary node sampling over a period of five to ten days using the CyberKnife (CK). Subjects will receive CK before chemotherapy, if applicable.

Inclusion Criteria:

• DCIS or infiltrating ductal carcinoma of the breast <= 3cm
• margins clear by at least 2 mm
• age >=45 years

Exclusion Criteria:

• invasive lobular carcinoma
• multicentric disease
• nodal metastases
• breast implants
• pregnancy
• connective tissue disease