Stereotactic Guided Biopsy and Cryoablation

Stereotactic Guided Biopsy and Cryoablation of Breast Cancer

The purpose of this study is to evaluate a new strategy to treat small breast cancer called cryoablation, or cryosurgery, in combination with biopsy methods which are guided by certain imaging like mammography.

For participants who choose to enroll in this study, the doctor will perform an excisional biopsy to remove the tumor (a biopsy to attempt to remove the whole tumor), after which a clip will be placed. Using the clip as a guide, the doctor will then cryoablate the biopsy cavity. Cryoablation is a kind of treatment that uses a hollow, thin tube, called a cryoprobe, to kill any residual tumor by freezing it. By conducting this study, the research team will investigate whether biopsy followed by cryoablation guided by mammography will prove to be an effective and safe way of treating breast cancers. It is anticipated that participation in this research will last about 2 years.

Inclusion Criteria:

• Age 60 years or older, European Cooperative Oncology Group (ECOG) score 0-2
• Lesion size 1.0 cm or smaller in greatest diameter. The largest diameter will be determined at the time of the diagnostic work up. For targets that are imaged in multiple modalities the largest diameter will prevail in determining eligibility. Note- 1.0 cm target size is chosen since extent may be underestimated upon initial diagnosis.
• Biopsy proven DCIS, (including any lesion with DCIS +/- IDC)
• Closest margin of target to the skin >15 mm
• Compressed breast thickness to > 55mm
• Unifocal primary disease (Patients with contralateral disease will remain eligible.)
• Able to provide consent

Exclusion Criteria:

• Multifocal or multicentric disease within the breast.
• Prior surgical biopsy for diagnosis or treatment of index lesion.
• Patients not suitable for stereotactic biopsy/cryoablation technique according to treating physician.
• Patients receiving neoadjuvant therapy.
• History of previously treated ipsilateral or contralateral breast carcinoma is not an exclusion criterion if the investigator is certain newly diagnosed carcinoma is a new unifocal primary tumor.
• High-risk pathology (e.g., Grade 3, HER2+ status, Genomic high-risk score (if available)).