Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - Any
Updated:3/7/2019
Start Date:October 2014
End Date:December 2024

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Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)

To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and
distant recurrence of early stage breast cancer .


Inclusion Criteria:

1. Competent to sign informed consent

2. Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the
following criteria:

1. Unifocal primary disease NOTE: Patients with multifocal and/or multicentric in
breast cancer, or evidence of EIC are NOT eligible. Patients with contralateral
disease will remain eligible.

2. Tumor size ≤1.5 cm in greatest diameter in the axis parallel to the treatment
probe AND ≤1.5 cm in the axis anti-parallel to the treatment probe AND ≤1.5 cm in
Anterior/ Posterior dimension. Tumor size ≤1.5 cm in greatest diameter as
measured by breast ultrasound, mammogram and/or MRI. The largest dimension
measured will be used to determine eligibility.

3. Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than
or equal to 2.

4. Estrogen receptor positive, progesterone receptor positive, HER2 negative

3. Age>= 50

4. Breast size adequate for safe cryoablation

5. Lesion must be sonographically visible at the time of treatment.

6. History of previously treated ipsilateral or contralateral breast carcinoma is not an
exclusion criteria if the investigator is certain newly diagnosed carcinoma is new
unifocal primary tumor.

Exclusion Criteria:

1. Presence of lobular carcinoma

2. Presence of luminal B pathology

3. Nottingham score of 3 (specially nuclear and mitotic score>2)

3. Presence of microinvasion, or invasive breast carcinoma with extensive intraductal
component (EIC) 4. Presence of multifocal and/or multicentric in breast cancer 5. Presence
of multifocal calcifications 6. Presence of prior or concurrent neoadjuvant chemotherapy
for breast cancer
We found this trial at
19
sites
Germantown, Tennessee 38138
Principal Investigator: Richard E. Fine, MD
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Germantown, TN
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Linda K Han, MD
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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3615 New Mexico 528
Albuquerque, New Mexico 87114
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Albuquerque, NM
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Cincinnati, Ohio 45227
Principal Investigator: Karen S Columbus, MD
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Cincinnati, OH
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Cleveland, Ohio 44012
Principal Investigator: Jill R Dietz, MD
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Cleveland, OH
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Dalton, Georgia 30720
Principal Investigator: Eric R Manahan, MD
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Dalton, GA
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Detroit, Michigan 48201
Principal Investigator: Hussein D Aoun, MD
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Detroit, MI
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Flint, Michigan 48507
Principal Investigator: Randy Hicks, MD
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Flint, MI
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Freehold, New Jersey 07728
Principal Investigator: Kenneth Tomkovich, MD
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Freehold, NJ
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Glendale, Arizona 85306
Principal Investigator: Rashmi P Vaidya, MD
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Glendale, AZ
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New York, New York 10021
Principal Investigator: Rache Simmons, MD
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New York, NY
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New York, New York 10003
Principal Investigator: Sarah Cate, MD
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New York, NY
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New York, New York 10032
Principal Investigator: Margaret Chen-Seetoo, MD
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New York, NY
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New York, New York 10467
Principal Investigator: Beatriu Reig, MD
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New York, NY
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Alexander Sevrukov, MD
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Philadelphia, PA
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Plano, Texas 75075
Principal Investigator: Beth Anglin, MD
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Plano, TX
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Santa Ana, California 92705
Principal Investigator: Lisa Curcio, MD
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Santa Ana, CA
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Troy, Michigan 48085
Principal Investigator: Linsey Gold, MD
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Troy, MI
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Trumbull, Connecticut 06611
Principal Investigator: Andrew Kenler, MD
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Trumbull, CT
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