Cryoablation of Small Breast Tumors in Early Stage Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - Any
Updated:4/22/2018
Start Date:November 2013
End Date:June 2023
Contact:Pamela Ellis
Email:clinical@sanarus.com
Phone:(925) 460-6080

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

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.

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

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
We found this trial at
12
sites
Wynnewood, Pennsylvania 19096
Principal Investigator: Ned Z Carp, M.D.
Phone: 484-476-2395
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Robert Ward, M.D>
Phone: 401-444-2277
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Beverly Hills, California 90210
Principal Investigator: Dennis R. Holmes, MD, FACS
Phone: 310-651-2050
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Duarte, California 91010
Phone: 626-218-0433
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Emeryville, California 94608
Phone: 510-629-6682
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Knoxville, Tennessee 37909
Principal Investigator: Kamilia Kozlowski, MD
Phone: 865-583-1014
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Lubbock, Texas 79430
Principal Investigator: Rakhshanda Rahman, MD
Phone: 806-775-8597
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7500 SW 87th Ave # 100
Miami, Florida 33173
Phone: 305-740-5100
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Miami, FL
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Naples, Florida 34102
Principal Investigator: Sharla Patterson, MD
Phone: 239-624-8120
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Naples, FL
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5475 South 500 East
Ogden, Utah 84405
Principal Investigator: Jose Tamayo, MD
Phone: 801-479-2067
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Ogden, UT
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Rochester, Michigan 48307
Principal Investigator: Peter J. Littrup, M.D.
Phone: 248-652-5626
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Rochester, MI
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8896 East Becker Lane
Scottsdale, Arizona 85260
Principal Investigator: Belinda Barcley-White, MD
Phone: 480-314-7600
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