Status:
COMPLETED
Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial
Lead Sponsor:
IceCure Medical Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2024
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT02200705
Start Date
October 1 2014
End Date
May 26 2024
Last Update
April 30 2025
Active Locations (19)
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1
Ironwood Cancer & Research Centers
Glendale, Arizona, United States, 85306
2
BreastLink
Santa Ana, California, United States, 92705
3
Bridgeport Hospital, Yale Medical School
Trumbull, Connecticut, United States, 06611
4
Dalton Surgical Group
Dalton, Georgia, United States, 30720