Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer

Phase 2

• Conditions: Breast Cancer
• Interventions: Procedure: cryosurgery; Procedure: therapeutic conventional surgery

• Registration Number: NCT00723294
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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

Study Timeline

• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-28
• Study Start: 2008-09
• Primary Completion: 2013-09
• Results First Submitted: 2016-11-28
• Results First Submitted QC: 2017-01-17
• Results First Posted: 2017-03-07
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (cryoablation)	cryosurgery	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.
Treatment (cryoablation)	therapeutic conventional surgery	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.

Primary Outcome Measures

Name	Time	Method
Rate of Complete Tumor Ablation	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 Outcome Measures

Name	Time	Method
Negative Predictive Value of MRI	Up to 14 days post cryoablation	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.
Adverse Events	Up to 14 days post surgery
Pain Assessment	Up to 14 days post surgery

Trial Locations

Locations (16)

Indiana University Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Bellingham Breast Center; 🇺🇸 Bellingham, Washington, United States

Providence Saint Joseph Medical Center; 🇺🇸 Burbank, California, United States

Northwest Community Hospital; 🇺🇸 Arlington Heights, Illinois, United States

Indiana University Hospital/Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Bethesda North Hospital; 🇺🇸 Cincinnati, Ohio, United States

William Beaumont Hospital-Royal Oak; 🇺🇸 Royal Oak, Michigan, United States

New York Weill Cornell Cancer Center at Cornell University; 🇺🇸 New York, New York, United States

Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Lankenau Cancer Center at Lankenau Hospital; 🇺🇸 Wynnewood, Pennsylvania, United States

M. D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States

University of South Florida College of Medicine; 🇺🇸 Tampa, Florida, United States

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

DeCesaris Cancer Institute at Anne Arundel Medical Center; 🇺🇸 Annapolis, Maryland, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States