Brief Summary
To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .
Brief Title
Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial
Categories
Completion Date
Completion Date Type
Actual
Conditions
Breast Cancer
Eligibility Criteria
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
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
Inclusion Criteria
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
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
Gender
Female
Gender Based
false
Keywords
cryoablation, cryotherapy, breast cancer
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
50 Years
NCT Id
NCT02200705
Org Class
Industry
Org Full Name
IceCure Medical Ltd.
Org Study Id
ICMBC-02
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)
Primary Outcomes
Outcome Description
6 months post cryoabltion, then annually for 5 years
Outcome Measure
Local Inbreast Breast Tumor Recurrence (IBTR) Rate
Outcome Time Frame
up to 5 years
Secondary Outcomes
Outcome Description
Complete ablation of primary tumor up to 60 months after cryoablation
Outcome Time Frame
up to 5 years from procedure date.
Outcome Measure
Complete Ablation of Primary Tumor
Outcome Description
Quality of life will be assesed using NCCN DISTRESS THERMOMETER
Outcome Time Frame
at 6 months compare to the base line
Outcome Measure
Improvement or Maintenance of Subject's Quality of Life
Outcome Description
subjects and physician satisfaction from the cosmetic results
Outcome Time Frame
up to 5 years from procedure data.
Outcome Measure
Breast Cosmetics Satisfaction
Outcome Description
Regional Invasive breast tumor recurrence rate.
Outcome Time Frame
up to 5 years
Outcome Measure
Regional Recurrence Rate
Outcome Description
Distant metastases rate including contralateral Breast cancer
Outcome Time Frame
up to 5 years
Outcome Measure
Distant Metastases Rate
Outcome Description
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
Outcome Time Frame
up to 5 years
Outcome Measure
Disease-free Survival (DFS)
Outcome Description
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
Outcome Time Frame
up to 5 years
Outcome Measure
Overall Survival
Outcome Description
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.
Outcome Time Frame
up to 5 years
Outcome Measure
Breast Cancer Survival.
Outcome Description
Adverse events related to study device or procedure rate
Outcome Time Frame
up to 2 years for AEs and up to 5 years for SAEs
Outcome Measure
Adverse Events
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
50
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sheldon Feldman
Investigator Email
sfeldman@montefiore.org