Low-Risk, Early Stage Breast Cancer
Conditions
Keywords
Cancer, Breast Cancer, Cryoabalation
Brief summary
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.
Interventions
DEVICECryoablation
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.
Sponsors
IceCure Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR) Rate | 5 Years | The percentage of patients who develop confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation. |
| Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate | 5 Years | The percentage of patients who develop confirmed Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events (related/non-related to device and procedure). | 5 Years | The number, nature, and percentage of patients experiencing serious adverse events (SAEs), related and non-related to the device and procedure. |
| Disease-Free Survival (DFS) rate | 5 Years | The percentage of patients without evidence of IBTR, regional, or distant breast cancer recurrence, contralateral breast cancer, or death due to breast cancer. |
| Overall Survival (OS) rate | 5 Years | The percentage of participants who did not experience death due to any cause up to 5 years. |
| Complete Primary Tumor Ablation Rate | 6 Months | 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. |
| Procedure duration (minutes) | The day of the procedure | Procedure duration, defined as the time from procedure initiation to procedure completion, measured in minutes |
| Number of hospitalization days following the procedure | 6 Months | Length of post-procedural hospitalization (If needed), measured as the number of days from the procedure until hospital discharge. |
| Days to resume normal activity | 6 Months | Number of days after cryoablation until return to routine daily activities, as reported by the patient. |
| Number of procedure-related outpatient visits | 6 Months | Number of procedure-related outpatient visits post the procedure, which are unplanned in the study schedule of activities |
| Physician's satisfaction with the breast's cosmetic results | 6 Months | 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). |
| Non-serious adverse events (related/non-related to device and procedure) and procedure-related complications. | 6 Months | 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. |
| Local recurrence and Second primary breast cancer rates | 5 Years | The percentage of patients with local breast cancer recurrence or second primary breast cancer. |
| Patient's satisfaction with cosmetic outcomes | 5 Years | 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. |
| Patients' Quality of life (QoL) | 5 Years | 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. |
| Breast cancer survival rate | 5 Years | The percentage of patients who did not experience death due to breast cancer up to 5 years. |
| Locoregional recurrence (LRR) rate | 5 Years | The percentage of patients who develop locoregional recurrence within 5 years post-procedure. |
| Rate of discontinuation of routine follow-up procedures | 5 Years | The percentage of patients who discontinue routine breast-related follow-up procedures. |
Countries
United States
Contacts
CONTACTEidan Loushi Clinical Operations Specialist, M.Sc.
CONTACTRonit Lipson, Clinical Trial Manager
Outcome results
None listed