Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT02200705

Run by

IceCure Medical Ltd.

People needed

206

Starts

2014-10-01

Expected to finish

2024-05-26

Last updated by the study team

2026-07-07

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Competent to sign informed consent
• Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
• 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.
• 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.
• Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than or equal to 2.
• Estrogen receptor-positive, progesterone receptor-positive, HER2 negative
• Age>= 50
• Breast size adequate for safe cryoablation
• Lesion must be sonographically visible at the time of treatment.
• 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.

You may not qualify if…

• Presence of lobular carcinoma
• Presence of luminal B pathology
• Nottingham score of 3 (specially nuclear and mitotic score>2)
• Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC)
• Presence of multifocal and/or multicentric in breast cancer
• Presence of multifocal calcifications
• Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer
• Presence of prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
• Patient that is not suitable to cryoablation procedure according to the physician opinion
• ER AND PR negative, or Her2 positive noted on pre-cryo biopsy

Where it is running

• Ironwood Cancer & Research Centers — Glendale, Arizona, United States
• BreastLink — Santa Ana, California, United States
• Bridgeport Hospital, Yale Medical School — Trumbull, Connecticut, United States
• Dalton Surgical Group — Dalton, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Regional Medical Imaging — Flint, Michigan, United States
• Comprehensive Breast Care — Troy, Michigan, United States
• CentraState Medical Center — Freehold, New Jersey, United States
• Breast Specialty care/ Presbyterian Hospital — Albuquerque, New Mexico, United States
• Mount Sinai Beth Israel — New York, New York, United States
• Columbia University/ NY Presbyterian hospital — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Montefiore Medical Center — New York, New York, United States
• Cincinnati Breast Surgeons Inc. — Cincinnati, Ohio, United States
• University hospitals cleveland medical center — Cleveland, Ohio, United States
• Thomas Jefferson University hospital — Philadelphia, Pennsylvania, United States
• West Clinic — Germantown, Tennessee, United States
• Complete Breast Care — Plano, Texas, United States

Full record on ClinicalTrials.gov

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