A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 99
- Locations
- 16
- Primary Endpoint
- Rate of Complete Tumor Ablation
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of Complete Tumor Ablation
Time Frame: Up to 14 days post surgery
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).
Secondary Outcomes
- Negative Predictive Value of MRI(Up to 14 days post cryoablation)
- Adverse Events(Up to 14 days post surgery)
- Pain Assessment(Up to 14 days post surgery)