Focused Ultrasound and Gemcitabine in Breast Cancer

Inclusion Criteria: * Disease Status * Patients must have histologically confirmed, newly diagnosed breast cancer, stage 1-3 disease and be appropriate surgical candidates for complete resection. Recurrent disease patients must have disease localized to the breast, chest wall or axilla and must be surgical candidates for completion resection of recurrent disease. * If genomic profiling is performed, then the results must indicate that the cancer is high-risk * Any receptor status may be eligible (estrogen receptor, progesterone receptor, HER2 receptor) * Patients must have a lesion in the breast/chest wall/axilla that is accessible to focused ultrasound ablation. Accessible is defined as the following: * A targetable portion of the tumor must be ≥ 5mm from the skin * The rib cage should not be in the prefocal ultrasound path or behind the target area of the lesion (minimum distance from the posterior aspect of the target area to rib cage must be at least 10 mm). Participants must have at least one high-risk feature of breast cancer (tumor size and nodal status may be measured by mammogram, MRI, US, CT, or calipers): * Triple negative breast cancer with Tumor size ≥10mm * Lymph node involvement by imaging or biopsy (any receptor status, any size) * Tumor size ≥ 20mm (estrogen receptor positive, HER2 negative) * Tumor size ≥ 10mm (HER2 receptor positive, any ER status) * Tumor size ≥ 10mm and Oncotype or Mammaprint high status (estrogen receptor positive, HER2 neg…