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Purpose

The FDA has granted marketing authorization for the ProSense® Cryoablation System for the local treatment of patients aged 70 years or older with low-risk early-stage breast cancer who are also receiving adjuvant hormone therapy. This clinical trial is designed to collect additional data on the safety and effectiveness of cryoablation when used as part of routine clinical care. Specifically, the study will evaluate recurrence rates following the procedure for up to 5 years post-treatment. In addition, linkage to claims data will be used to assess long-term outcomes, including breast cancer-related surgeries, mammograms and other breast imaging procedures, breast biopsies, and all-cause mortality.

Condition

Eligibility

Eligible Ages
Over 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Provision of a signed and dated informed consent form. 2. Age ≥70 3. Diagnosis of invasive ductal breast carcinoma (IDC) by core needle biopsy, meeting the following criteria: - Unifocal primary disease - Tumor size ≤1.5 cm in greatest diameter - Estrogen receptor positive, Progesterone receptor positive, and HER2 negative - Low-risk tumor biology, defined as Ki67<15% or confirmed by genomic testing. In cases where Ki67 is ≥15%, low-risk status must be confirmed by genomic testing, which will prevail. 4. Lesions must be sonographically visible at the time of treatment 5. Clinically negative lymph node (N0).

Exclusion Criteria

  1. Presence of lobular carcinoma. 2. Presence of microinvasion or invasive breast carcinoma with extensive intraductal component (EIC), defined as DCIS component comprising ≥25%. 3. Evidence of lymphovascular invasion. 4. Presence of multifocal and/or multicentric breast cancer. 5. Presence of multifocal suspicious calcifications. 6. Presence of inflammatory features. 7. Previous ipsilateral breast radiation 8. Neoadjuvant endocrine treatment is provided to reduce the tumor size. 9. Prior or concurrent neoadjuvant chemotherapy, biological therapy, or other targeted neo-therapies. 10. Prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. 11. Allergy to local anesthesia. 12. Any other reason defined as inoperable declared by a physician.

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
Experimental
Low-risk, Early satge breast cancer 		FDA-Approved cryoablation procedure for the indicated population
  • Device: Cryoablation
    Cryoablation procedure, without resection, using the IceCure Medical ProSense® Cryoablation System. Patients will be also provided with adjuvant endocrine therapy for 5 years post-treatment. The IceCure ProSense® cryoablation system is intended for cryogenic destruction of tissue by the application of extreme cold temperatures.

Recruiting Locations

Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Glendale, California 91206
Contact:
Lily Villalobos
818-539-9185
villall3@ah.org

The West Clinic, PC dba West Cancer Center
Germantown, Tennessee 38138
Contact:
Lucy Lasher
901-683-0055
IRBApprovals@westclinic.com

More Details

Status
Recruiting
Sponsor
IceCure Medical Ltd.

Study Contact

Eidan Loushi Clinical Operations Specialist, M.Sc.
+972-548118632
eidanl@icecure-medical.com

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.