Purpose

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

Condition

Eligibility

Eligible Ages
Over 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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) 4. Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC) 5. Presence of multifocal and/or multicentric in breast cancer 6. Presence of multifocal calcifications 7. Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer 8. Presence of prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer 9. Patient that is not suitable to cryoablation procedure according to the physician opinion 10. ER AND PR negative, or Her2 positive noted on pre-cryo biopsy

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
single arm, open label
Early stage Breast cancers up to 1.5cm
  • Device: Ice-Sense3TM/ ProSenseTM

More Details

Status
Active, not recruiting
Sponsor
IceCure Medical Ltd.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.