This phase II trial is studying how well cryoablation therapy works in treating patients with invasive ductal breast cancer. Cryoablation kills tumor cells by freezing them. This may be an effective treatment for patients with invasive ductal breast cancer.
This is a phase II non-randomized exploratory study. All fully eligible and registered patients will undergo imaging by mammography, ultrasound, and breast MRI. Patients will then undergo complete surgical resection of the primary tumor. The primary and secondary objectives of the study are described below. OBJECTIVES: Primary * To determine the rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion Secondary * To evaluate the negative predictive value of MRI in the post-ablation setting to determine residual in situ or invasive breast carcinoma * To describe the adverse events associated with cryoablation * To prospectively gather pain assessment data on cryoablation and surgical resection * Explore technical variables that may affect the success of cryoablation
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Providence Saint Joseph Medical Center
Burbank, California, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Rate of Complete Tumor Ablation
The primary endpoint for this study is the rate of complete ablation. Complete ablation is defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion. The rate (percentage) will be computed as the number of patient lesions with complete tumor ablation divided by the total number of eligible patient lesions. This rate will be estimated by the binomial point estimate (number of patients with no pathological evidence of residual disease in the targeted lesion after ablation divided by the number of eligible patients) and a one-sided 90% binomial confidence interval (interval with a lower bound).
Time frame: Up to 14 days post surgery
Negative Predictive Value of MRI
Negative predictive value of MRI: The negative predictive rate of MRI will be estimated as the number of patients with no residual disease upon pathologic review of the resected tissue AND with a MRI that indicated no residual disease divided by the number of patients who had an MRI that indicated no residual disease. Both a binomial point estimate and 90% two-sided confidence interval will be computed.
Time frame: Up to 14 days post cryoablation
Adverse Events
Time frame: Up to 14 days post surgery
Pain Assessment
Time frame: Up to 14 days post surgery
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...and 6 more locations