NCT00723294

Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer

A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	cryosurgery
PROCEDURE	therapeutic conventional surgery

Timeline

• Start date: 2008-09-01
• Primary completion: 2013-09-01
• First posted: 2008-07-28
• Last updated: 2017-08-14
• Results posted: 2017-03-07

Locations

16 sites across 1 country: United States