Breast Cancer Clinical Trial

Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial

Summary

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

208

Study ID:

NCT02200705

Recruitment Status:

Completed

Sponsor:

IceCure Medical Ltd.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 19 Locations for this study

See Locations Near You

Ironwood Cancer & Research Centers
Glendale Arizona, 85306, United States
BreastLink
Santa Ana California, 92705, United States
Bridgeport Hospital, Yale Medical School
Trumbull Connecticut, 06611, United States
Dalton Surgical Group
Dalton Georgia, 30720, United States
Indiana University
Indianapolis Indiana, 46202, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Regional Medical Imaging
Flint Michigan, 48507, United States
Comprehensive Breast Care
Troy Michigan, 48085, United States
CentraState Medical Center
Freehold New Jersey, 07728, United States
Breast Specialty care/ Presbyterian Hospital
Albuquerque New Mexico, 87114, United States
Mount Sinai Beth Israel
New York New York, 10011, United States
Columbia University/ NY Presbyterian hospital
New York New York, 10032, United States
Weill Cornell Medical College
New York New York, 10065, United States
Montefiore Medical Center
New York New York, 10467, United States
Cincinnati Breast Surgeons Inc.
Cincinnati Ohio, 45227, United States
University hospitals cleveland medical center
Cleveland Ohio, 44106, United States
Thomas Jefferson University hospital
Philadelphia Pennsylvania, 19107, United States
West Clinic
Germantown Tennessee, 38138, United States
Complete Breast Care
Plano Texas, 75075, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

208

Study ID:

NCT02200705

Recruitment Status:

Completed

Sponsor:


IceCure Medical Ltd.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.