Clinical trial NCT01992250: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Cryoablation
Lead sponsor: Sanarus Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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

Primary outcomes:
measure: Tumor ablation occurence
timeFrame: Within 6 months
Secondary outcomes:
measure: Local tumor recurrence
timeFrame: Within 5 years
measure: Satisfactory breast cosmesis results
timeFrame: 5 Years
measure: Adverse event assessment
timeFrame: 5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Breastnet
state: Arizona
city: Beverly Hills
country: United States
facility: 90210 Surgery Medical Center
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: Emeryville
country: United States
facility: Epic Care
state: California
city: Miami
country: United States
facility: Diagnostic Center for Women, LLC
state: Florida
city: Naples
country: United States
facility: Naples Community Hospital
state: Florida
city: Rochester
country: United States
facility: Ascension Crittenton Hospital
state: Michigan
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Knoxville
country: United States
facility: Knoxville Comprehensive Breast Center
state: Tennessee
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Ogden
country: United States
facility: Ogden Regional Hospital
state: Utah
Study officials:
affiliation: 90210 Surgery Medical Center
name: Dennis R. Holmes, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: