Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer

Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer

This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group.

Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.

Inclusion Criteria:

• Ultrasound visible invasive ductal carcinoma (IDC) diagnosed by core needle biopsy;
• Tumor visible by ultrasound at time of treatment;
• Unifocal primary disease;
• Tumor size between 0.5 cm and 2.0 cm (as measured on ultrasound);
• Tumor depth ≥ 0.5 cm from the skin or nipple-areola complex;
• Planned lumpectomy

Exclusion Criteria:

• Pregnant patients
• Multifocal or metastatic disease
• Planned neoadjuvant chemotherapy or radiation
• Extensive ductal carcinoma in situ (DCIS; >25% DCIS component) either diagnosed on core biopsy or strongly suggested by imaging
• Known allergy to both lidocaine and benzocaine