Alternatives to traditional breast cancer surgery are being sought to provide treatment options that are psychologically and cosmetically more acceptable to the patient. Our preliminary data suggests that Image-guided Vacuum-assisted Excisional Biopsy (IVEB), via single needle insertion, provides immediate and accurate diagnosis and sufficient removal of benign breast lesions. However, complete margin evaluation of malignant lesions cannot be performed with IVEB, imaging expertise is required, and the relative tumor disturbance caused by removing the tumor in pieces (cores) is unknown. We propose to develop a minimally invasive treatment paradigm that combines single-insertion IVEB with ablation (via laser or radiofrequency) to achieve complete tumor excision, full histological knowledge, and negative margins. Our primary long-range objective is to develop a comprehensive system for same-day diagnosis and oncologically sound extirpation of small less than or equal too 1.5 cm), unicentric breast cancers. We hypothesize that laser or radiofrequency ablation after single-insertion IVEB can be used to achieve negative margins in unicentric breast cancers that are less than or equal too 1.5 cm in diameter (staged as less than or equal too T1c). We will test this hypothesis by quantifying the degree of tumor-free margin achieved with IVEB followed by ablation in a Phase I/II clinical trial (Specific Aim 1). This study combines cutting-edge, but proven, technologies to create a novel paradigm in order to meet the patient's need for rapid diagnosis and minimally invasive treatment of breast cancer lesions and overcome many of the problems currently associated with breast conservation therapy. Completion of this study will indicate the efficacy and safety of IVEB in combination with ablation, setting the stage for a future multi-center Phase III trial randomizing the resultant technology with traditional lumpectomy.
| Klimberg, V Suzanne; Boneti, Cristiano; Adkins, Laura L et al. (2011) Feasibility of percutaneous excision followed by ablation for local control in breast cancer. Ann Surg Oncol 18:3079-87 |
