Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer
RATIONALE: Cryoablation kills tumor cells by freezing them. This may be an effective treatment for patients with invasive ductal breast cancer.
PURPOSE: This phase II trial is studying how well cryoablation therapy works in treating patients with invasive ductal breast cancer.
Procedure: therapeutic conventional surgery
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma|
- Rate of complete tumor ablation [ Designated as safety issue: No ]
- Negative predictive value of MRI [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
- Pain assessment [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
- To determine the rate of complete tumor ablation in patients with invasive ductal breast carcinoma treated with cryoablation.
- To evaluate the negative predictive value of MRI in the post-ablation setting in detecting residual in situ or invasive breast carcinoma.
- To describe the adverse events associated with cryoablation in these patients.
- To prospectively gather pain assessment data before and after cryoablation and after surgical resection in these patients.
- To explore technical variables that may affect the success of cryoablation in these patients.
OUTLINE: This is a multicenter study.
A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
Patients complete the Brief Pain Inventory before and after cryoablation and after surgery.
After completion of study treatment, patients are followed within 14 days.
|United States, Connecticut|
|Bridgeport, Connecticut, United States, 06610|
|Contact: Clinical Trials Office - Bridgeport Hospital 203-384-4869|
|United States, Illinois|
|Northwest Community Hospital||Recruiting|
|Arlington Heights, Illinois, United States, 60005|
|Contact: Michael R. Kinney 847-618-6660|
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center||Recruiting|
|Indianapolis, Indiana, United States, 46202-5289|
|Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552|
|United States, Maryland|
|DeCesaris Cancer Institute at Anne Arundel Medical Center||Recruiting|
|Annapolis, Maryland, United States, 21401|
|Contact: Lorraine Tafra, MD 443-481-5300|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109-0942|
|Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125|
|United States, New York|
|New York Weill Cornell Cancer Center at Cornell University||Recruiting|
|New York, New York, United States, 10021|
|Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848|
|United States, Ohio|
|Bethesda North Hospital||Recruiting|
|Cincinnati, Ohio, United States, 45242|
|Contact: Susan Weinberg 513-745-1111|
|United States, Pennsylvania|
|Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center||Recruiting|
|Hershey, Pennsylvania, United States, 17033-0850|
|Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a 717-531-3779 CTO@hmc.psu.edu|
|Lankenau Cancer Center at Lankenau Hospital||Recruiting|
|Wynnewood, Pennsylvania, United States, 19096|
|Contact: Ned Z. Carp, MD 610-642-1908|
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas||Recruiting|
|Houston, Texas, United States, 77030-4009|
|Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245|
|United States, Washington|
|Bellingham Breast Center||Recruiting|
|Bellingham, Washington, United States, 98225|
|Contact: Cary S. Kaufman 360-671-9877|
|Study Chair:||Rache M. Simmons, MD||Weill Medical College of Cornell University|