Clinical Trials /

Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

NCT01992250

Description:

This study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT01992250

Trial Eligibility

Document

Title

  • Brief Title: Cryoablation of Small Breast Tumors in Early Stage Breast Cancer
  • Official Title: Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: CP-00-0011
  • NCT ID: NCT01992250

Conditions

  • Breast Cancer

Purpose

This study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.

Detailed Description

      PURPOSE:

      To determine the rate of successful tumor ablation in patients treated with cryoablation and
      endocrine therapy in a subset of patients with early stage breast cancer.

      OUTLINE:

        1. Core Biopsy (Pre-Registration)

        2. Magnetic Resonance Imaging (Pre-Registration)

        3. Tumor Cryoablation

        4. Core Biopsy (Post-Cryoablation)

        5. Magnetic Resonance Imaging (Post-Cryoablation)

        6. Postoperative Follow-up

        7. Evaluation of outcomes

Trial Arms

NameTypeDescriptionInterventions
Low Risk - Age 70+OtherAge 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
    Moderate Risk - Age 50-69OtherAge between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies

      Eligibility Criteria

              Inclusion Criteria:

          1. Age ≥ 50

          2. Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy

          3. Maximum tumor size ≤1.5 cm in its greatest diameter

          4. Ultrasound visible lesion(s)

          5. Clinically node negative, hormone receptor positive (+). HER2 negative (-), with <25%
             intraductal component in the aggregate.

          6. Unilateral or bilateral disease meeting study criteria

          7. Physical and emotional ability to undergo baseline and follow-up breast MRIs and
             serial breast cosmesis analysis

          8. Patient agrees to receive a 5 year minimum course of endocrine therapy following
             cryoablation for control of systemic disease

        Exclusion Criteria:

          1. Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer

          2. Ductal carcinoma in-situ with microinvasions (T1mic)

          3. Multifocal or multicentric invasive breast carcinoma

          4. Prior or planned neoadjuvant systemic therapy for breast cancer

          5. Tumor with ≥25% IDC components
      Maximum Eligible Age:N/A
      Minimum Eligible Age:50 Years
      Eligible Gender:Female
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Tumor ablation occurence
      Time Frame:Within 6 months
      Safety Issue:
      Description:Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma. Will be determined at 6-month post-cryoablation biopsy. Residual disease will require surgery.

      Secondary Outcome Measures

      Measure:Local tumor recurrence
      Time Frame:Within 5 years
      Safety Issue:
      Description:
      Measure:Satisfactory breast cosmesis results
      Time Frame:5 Years
      Safety Issue:
      Description:
      Measure:Adverse event assessment
      Time Frame:5 years
      Safety Issue:
      Description:

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Sanarus Technologies, Inc.

      Trial Keywords

      • Cryoablation

      Last Updated

      April 20, 2018