A clinical approach to the development of interstitial therapy of primary breast cancer

In developing a clinical trial of interstitial therapy for small, mammographically discovered, core-biopsied, non-palpable primary breast cancers, several factors should be taken into account: the size and type of the primary breast cancer; the method of treatment and its capacity to kill all of the cancer and its supportive, surrounding stroma; the size of the proposed treatment field; the distance from the edge of this field to the skin and the chest wall; the technique of accurately placing the treatment probe; a method(s) for assessing treatment end point - both qualitatively and quantitatively; patient demographic information to assure an adequate population size; and considerations of treatment advantage as well as acceptance by patients and practitioners. For any new technology to enter the clinical arena, a need or at least some clinical advantage should exist. In this circumstance, performing an "incisionless lumpectomy" is perceived by patients to be that advantage. It is an extension of a therapeutic progression across the past century of breast surgery that has moved from the radical mastectomy through the modified radical mastectomy to the lumpectomy