Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB

Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial

To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.

Inclusion Criteria:

• Life expectancy > 10 years
• Lumpectomy with clear margins (negative per NSABP criteria)
• DCIS and/or invasive carcinoma
• If invasive, nodes must be negative
• T stage is Tis, T1 or T2<=3 cm max diameter
• ER(+) or ER(-)/PR(+)

Exclusion Criteria:

• Pregnant or breast feeding
• Active collagen-vascular disease
• Paget's disease of the breast
• Prior history of breast cancer
• Prior breast or thoracic radiotherapy
• Multicentric carcinoma
• Synchronous bilateral breast cancer
• Surgical margins that cannot be assessed or that are positive
• T Stage is T2>3 cm or greater
• ER(-)/PR(-)