Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-risk, Early satge breast cancer | Experimental | FDA-Approved cryoablation procedure for the indicated population |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate | The percentage of patients who develop confirmed Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation. | 5 Years |
| Confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR) Rate | The percentage of patients who develop confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation. | 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Primary Tumor Ablation Rate | The percentage of patients with complete tumor ablation, defined by adequate iceball coverage of the target tumor during the cryoablation procedure and absence of residual tumor at the 6-month follow-up. | 6 Months |
| Procedure duration (minutes) |
Not provided
Inclusion Criteria:
Provision of a signed and dated informed consent form.
Age ≥70
Diagnosis of invasive ductal breast carcinoma (IDC) by core needle biopsy, meeting the following criteria:
Lesions must be sonographically visible at the time of treatment
Clinically negative lymph node (N0).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eidan Loushi Clinical Research Associate | Contact | +972-548118632 | eidanl@icecure-medical.com | |
| Ronit Lipson, Clinical Trial Manager | Contact | +972-522337768 | ronitl@Icecure-medical.com |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39283572 | Background | Fine RE, Gilmore RC, Tomkovich KR, Dietz JR, Berry MP, Hernandez LE, Columbus KS, Seedman SA, Fisher CS, Han LK, Manahan ER, Hicks RD, Vaidya RP, Curcio LD, Sevrukov AB, Kenler AS, Taback B, Chen M, Miller ME, Gold L, Anglin BV, Aoun HD, Simmons RM, Feldman SM, Boolbol SK. Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence. Ann Surg Oncol. 2024 Oct;31(11):7273-7283. doi: 10.1245/s10434-024-16181-0. Epub 2024 Sep 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Procedure duration, defined as the time from procedure initiation to procedure completion, measured in minutes |
| The day of the procedure |
| Number of hospitalization days following the procedure | Length of post-procedural hospitalization (If needed), measured as the number of days from the procedure until hospital discharge. | 6 Months |
| Days to resume normal activity | Number of days after cryoablation until return to routine daily activities, as reported by the patient. | 6 Months |
| Number of procedure-related outpatient visits | Number of procedure-related outpatient visits post the procedure, which are unplanned in the study schedule of activities | 6 Months |
| Physician's satisfaction with the breast's cosmetic results | Assessed using the Sneeuw Questionnaire, an observer-rated assessment of cosmetic changes following treatment. Items are scored on a 4-point scale ranging from 1 (None) to 4 (Severe), with the overall cosmetic result rated from 1 (Poor) to 4 (Excellent). | 6 Months |
| Non-serious adverse events (related/non-related to device and procedure) and procedure-related complications. | Number, nature, and percentage of patients with non-serious adverse events (related/nonrelated to device and procedure) and procedure-related complications up to 6 months. | 6 Months |
| Local recurrence and Second primary breast cancer rates | The percentage of patients with local breast cancer recurrence or second primary breast cancer. | 5 Years |
| Patient's satisfaction with cosmetic outcomes | Patients' satisfaction will be assessed at 6-month follow-up and subsequent visits through 5 years using the 'Satisfaction with Breasts' scale from the BREAST-Q 2.0 Patient-Reported Outcome (PRO) Breast-Conserving Surgery module. Scores are reported on a 0 (Worst) to 100 (Best) scale. | 5 Years |
| Patients' Quality of life (QoL) | Improvement or maintenance of patient's quality of life will be evaluated at 6-month follow-up and subsequent visits through 5 years, compared to baseline, using two scales from the BREAST-Q 2.0 PRO Breast-Conserving Surgery module: Physical Well-Being: Chest, and Psychosocial Well-Being. BREAST-Q has domain scores reported on a 0 (Worst) to 100 (Best) scale. | 5 Years |
| Locoregional recurrence (LRR) rate | The percentage of patients who develop locoregional recurrence within 5 years post-procedure. | 5 Years |
| Disease-Free Survival (DFS) rate | The percentage of patients without evidence of IBTR, regional, or distant breast cancer recurrence, contralateral breast cancer, or death due to breast cancer. | 5 Years |
| Overall Survival (OS) rate | The percentage of participants who did not experience death due to any cause up to 5 years. | 5 Years |
| Breast cancer survival rate | The percentage of patients who did not experience death due to breast cancer up to 5 years. | 5 Years |
| Rate of discontinuation of routine follow-up procedures | The percentage of patients who discontinue routine breast-related follow-up procedures. | 5 Years |
| Serious adverse events (related/non-related to device and procedure). | The number, nature, and percentage of patients experiencing serious adverse events (SAEs), related and non-related to the device and procedure. | 5 Years |