Breast Cancer
Conditions
Keywords
cryoablation, cryotherapy, breast cancer
Brief summary
To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .
Interventions
DEVICEIce-Sense3TM/ ProSenseTM
Sponsors
IceCure Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Inbreast Breast Tumor Recurrence (IBTR) Rate | up to 5 years | 6 months post cryoabltion, then annually for 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Primary Tumor Ablation Rate | up to 5 years from procedure date. | Complete ablation of primary tumor up to 60 months after cryoablation, reported as the percentage of patients with complete tumor ablation. |
| Improvement or Maintenance of Subject's Quality of Life | Baseline and 6 months | Quality of life will be assessed using the NCCN Distress Thermometer, a 0-10 scale measuring patient distress (0 = no distress, 10 = extreme distress; higher scores indicate worse distress), collected at baseline and at 6 months follow-up visit. |
| Breast Cosmetics Satisfaction | Up to 5 years following procedure | Participants and treating physicians rated satisfaction with cosmetic outcomes following breast cryoablation. |
| Regional Recurrence Rate | up to 5 years following procedure | Regional Invasive breast tumor recurrence rate. |
| Distant Metastases Survival Rate | up to 5 years following procedure | Distant metastases survival rate, including contralateral Breast cancer |
| Disease-free Survival (DFS) | up to 5 years | DFS from the date of complete ablation of the primary tumor until the first disease event, where the disease event is defined as local (DCIS or invasive), regional, or distant breast cancer recurrence, or DCIS or invasive contralateral breast cancer. |
| Overall Survival | up to 5 years | Overall survival from the date of the cryoablation until the date of death from any cause or up to the 60 months follow up visit |
| Breast Cancer Survival. | up to 5 years | Breast Cancer Survival from the date of cryoablation until the date of death from breast cancer or up to the 60 months follow-up visit. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 19 sites in the USA. All study investigators had related experience in low-risk breast cancer treatment, imaging, and pathology assessments and were trained to perform the cryoablation procedure. The recruitment period lasted from October 2014 to February 2019.
Pre-assignment details
A total of 212 Subjects were screened for enrollment in the study; 3 were screen failures, and 3 subjects withdrew consent before the procedure; 206 were enrolled and treated. Based on the DSMB recommendation, 12 subjects were excluded from the study after completing the cryoablation procedure. Nine (9) were due to deviation from inclusion criteria, and three (3) were due to incomplete treatment, resulting in the per-protocol study population of 194 subjects.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm, Open Label Subjects with early-stage (up to 1.5 cm), low-risk breast cancer who met the eligibility criteria outlined in the study protocol were enrolled and underwent cryoablation using the IceCure Medical Ice-Sense3™/ProSense™ system. | 194 |
| Total | 194 |
Baseline characteristics
| Characteristic | Single Arm, Open Label |
|---|---|
| Age, Continuous | 74.9 years STANDARD_DEVIATION 6.9 |
| ER (Estrogen Receptor) Negative | 0 Participants |
| ER (Estrogen Receptor) Positive | 194 Participants |
| Her2neu Negative | 194 Participants |
| Her2neu Positive | 0 Participants |
| Nottingham Grade (1-3) Grade 1 (Low grade) - Least aggressive with good prognosis | 96 Participants |
| Nottingham Grade (1-3) Grade 2 (Intermediate-grade tumor) - Moderate aggressiveness and prognosis | 98 Participants |
| PR (Progesterone Receptor) Negative | 14 Participants |
| PR (Progesterone Receptor) Positive | 180 Participants |
| Race/Ethnicity, Customized Ethnicity African American | 14 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 160 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 12 Participants |
| Race/Ethnicity, Customized Ethnicity Native American | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Unknow | 5 Participants |
| Region of Enrollment United States | 194 participants |
| Sex: Female, Male Female | 194 Participants |
| Sex: Female, Male Male | 0 Participants |
| Type of Tumor Lumina A | 188 Participants |
| Type of Tumor Lumina B | 3 Participants |
| Type of Tumor Not specified | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 21 / 206 |
| other Total, other adverse events | 97 / 206 |
| serious Total, serious adverse events | 0 / 206 |
Outcome results
Primary
Local Inbreast Breast Tumor Recurrence (IBTR) Rate
6 months post cryoabltion, then annually for 5 years
Time frame: up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm, Open Label | Local Inbreast Breast Tumor Recurrence (IBTR) Rate | 4.3 Percentage of participants with IBTR |
Secondary
Adverse Events
Adverse events related to study device or procedure rate
Time frame: up to 2 years for AEs and up to 5 years for SAEs
Secondary
Breast Cancer Survival.
Breast Cancer Survival from the date of cryoablation until the date of death from breast cancer or up to the 60 months follow-up visit.
Time frame: up to 5 years
Secondary
Breast Cosmetics Satisfaction
subjects and physician satisfaction from the cosmetic results
Time frame: up to 5 years from procedure data.
Secondary
Complete Ablation of Primary Tumor
Complete ablation of primary tumor up to 60 months after cryoablation
Time frame: up to 5 years from procedure date.
Secondary
Disease-free Survival (DFS)
DFS from date of complete ablation of the primary tumor, until the first disease event where the disease event is defined as local (DCIS or invasive), regional, or distant breast cancer recurrence, second primary cancer, DCIS or invasive contralateral breast cancer, or death due to any cause
Time frame: up to 5 years
Secondary
Distant Metastases Rate
Distant metastases rate including contralateral Breast cancer
Time frame: up to 5 years
Secondary
Improvement or Maintenance of Subject's Quality of Life
Quality of life will be assesed using NCCN DISTRESS THERMOMETER
Time frame: at 6 months compare to the base line
Secondary
Overall Survival
Overall survival from the date of the cryoablation until the date of death from any cause or up to the 60 months follow up visit
Time frame: up to 5 years
Secondary
Regional Recurrence Rate
Regional Invasive breast tumor recurrence rate.
Time frame: up to 5 years