Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant Therapy

NCT01388777 | Terminated Phase 2 Results

• 2 other identifiers: 2010-0986NCI-2011-01278
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. The goal of this clinical research study is to learn about the level of effectiveness of using ultrasound-guided cryoablation in patients with invasive breast cancer. The safety of this procedure will also be studied.

Conditions

Breast Cancer

Keywords

Breast Cancer; Breast Carcinoma; Cryoablation; The Visica 2™ Treatment System; Unifocal primary invasive ductal breast carcinoma; Cryoprobe

Outcome Measures

Primary Outcomes (1)

• Rate of Complete Tumor Ablation

  The rate of complete tumor ablation in the target lesion will be evaluated by pathologic review of the surgical specimen.

  From cryoablation through 30 days from surgery

Study Arms (1)

Cryoablation

EXPERIMENTAL

Cryoablation therapy followed by re-imaging then complete surgical resection.

Device: Visica 2™ Treatment System; Procedure: Cryoablation; Procedure: Surgical Resection

Interventions

Visica 2™ Treatment System DEVICE

The Visica 2™ Treatment System uses a closed system to circulate liquid nitrogen within the probe tip creating sub-freezing temperatures that result in precision cryoablation of the intended target tissue.

Cryoablation

Cryoablation PROCEDURE

Cryoablation procedure uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. The cryoprobe needle insertion is done using ultrasound guide to reach target, procedure lasts about 20 minutes.

Cryoablation

Surgical Resection PROCEDURE

Complete surgical resection of the primary tumor following cryoablation therapy.

Also known as: Surgery

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or ductal carcinoma in situ (DCIS) with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible.
• Neoadjuvant chemotherapy or hormonal therapy for the index tumor is required.
• Residual tumor size \</= 2.0 cm in greatest diameter. Specifically, the tumor must measure \</= 2.0 cm in the axis parallel to the treatment probe and \</= 1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by mammogram, ultrasound or MRI will be used to determine eligibility.
• Tumor enhancement on pre-registration MRI.
• Tumor with \<25% intraductal components in the aggregate.
• Adequate breast size for safe cryoablation. Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation.
• Patients with prior in-situ or invasive breast carcinomas are eligible if the prior carcinomas occurred in the contralateral breast. Patients with prior in-situ or invasive carcinomas of the ipsilateral breast are not eligible.

You may not qualify if:

• History of open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. Note: Prior rotational and/or vacuum-assisted core biopsies are permitted if no significant distortion is seen on imaging that could obscure visualization and detection of residual disease on MRI, or visualization of cancer on ultrasound for cryoablation procedure.
• Pregnant and/or lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be amenorrheic for \> 12 months to be considered not of childbearing potential.
• Patient has contra-indication to an MRI examination, such as clips/prostheses/implants that are not MRI compatible, or compromised renal function, with a measured or calculated glomerular filtration rate of 60ml/min/1.73m\^2
• Patients less than 18 years of age will not be included in this study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryosurgery; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques

Limitations and Caveats

Early termination leading to small number of subjects analyzed.

Results Point of Contact

• Title: Hwang, Rosa, M.D.
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-7734

Study Officials

• Rosa Hwang, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 7, 2011
• Study Start: January 24, 2012
• Primary Completion: June 14, 2017
• Study Completion: June 14, 2017
• Last Updated: July 17, 2018
• Results First Posted: July 17, 2018

Record last verified: 2018-06

Locations

US (1)