Trial Outcomes & Findings for Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial (NCT NCT02200705)
NCT ID: NCT02200705
Last Updated: 2026-07-07
Results Overview
6 months post cryoabltion, then annually for 5 years
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
206 participants
Primary outcome timeframe
up to 5 years
Results posted on
2026-07-07
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
206
|
|
Overall Study
Per-protocol study population
|
194
|
|
Overall Study
COMPLETED
|
131
|
|
Overall Study
NOT COMPLETED
|
75
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Excluded
|
12
|
|
Overall Study
Death
|
21
|
|
Overall Study
Withdrawal by Subject
|
22
|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial
Baseline characteristics by cohort
| Measure |
Single Arm, Open Label
n=194 Participants
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.
|
|---|---|
|
Age, Continuous
|
74.9 years
STANDARD_DEVIATION 6.9 • n=20 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · African American
|
14 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
1 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Caucasian
|
160 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
12 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Native American
|
2 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknow
|
5 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
194 participants
n=20 Participants
|
|
Type of Tumor
Lumina A
|
188 Participants
n=20 Participants
|
|
Type of Tumor
Lumina B
|
3 Participants
n=20 Participants
|
|
Type of Tumor
Not specified
|
3 Participants
n=20 Participants
|
|
ER (Estrogen Receptor)
Positive
|
194 Participants
n=20 Participants
|
|
ER (Estrogen Receptor)
Negative
|
0 Participants
n=20 Participants
|
|
PR (Progesterone Receptor)
Positive
|
180 Participants
n=20 Participants
|
|
PR (Progesterone Receptor)
Negative
|
14 Participants
n=20 Participants
|
|
Her2neu
Positive
|
0 Participants
n=20 Participants
|
|
Her2neu
Negative
|
194 Participants
n=20 Participants
|
|
Nottingham Grade (1-3)
Grade 1 (Low grade) - Least aggressive with good prognosis
|
96 Participants
n=20 Participants
|
|
Nottingham Grade (1-3)
Grade 2 (Intermediate-grade tumor) - Moderate aggressiveness and prognosis
|
98 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: up to 5 years6 months post cryoabltion, then annually for 5 years
Outcome measures
| Measure |
Single Arm, Open Label
n=194 Participants
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.
|
|---|---|
|
Local Inbreast Breast Tumor Recurrence (IBTR) Rate
|
4.3 Percentage of participants with IBTR
Interval 2.1 to 8.7
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Single Arm, Open Label
n=194 Participants
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.
|
|---|---|
|
Complete Primary Tumor Ablation Rate
|
95.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsQuality 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.
Outcome measures
| Measure |
Single Arm, Open Label
n=194 Participants
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.
|
|---|---|
|
Improvement or Maintenance of Subject's Quality of Life
|
-0.7 scores on a scale
Standard Deviation 2.9 • Interval 10.0 to -10.0
|
SECONDARY outcome
Timeframe: Up to 5 years following procedureParticipants and treating physicians rated satisfaction with cosmetic outcomes following breast cryoablation.
Outcome measures
| Measure |
Single Arm, Open Label
n=194 Participants
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.
|
|---|---|
|
Breast Cosmetics Satisfaction
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: up to 5 years following procedureRegional Invasive breast tumor recurrence rate.
Outcome measures
| Measure |
Single Arm, Open Label
n=194 Participants
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.
|
|---|---|
|
Regional Recurrence Rate
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: up to 5 years following procedureDistant metastases survival rate, including contralateral Breast cancer
Outcome measures
| Measure |
Single Arm, Open Label
n=194 Participants
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.
|
|---|---|
|
Distant Metastases Survival Rate
|
96.4 Percentage of participants
Interval 92.2 to 98.4
|
SECONDARY outcome
Timeframe: up to 5 yearsDFS 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.
Outcome measures
| Measure |
Single Arm, Open Label
n=194 Participants
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.
|
|---|---|
|
Disease-free Survival (DFS)
|
92.8 Percentage of participants
Interval 87.6 to 95.8
|
SECONDARY outcome
Timeframe: up to 5 yearsOverall 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 measures
| Measure |
Single Arm, Open Label
n=194 Participants
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.
|
|---|---|
|
Overall Survival
|
88.6 Percentage of participants
Interval 82.9 to 92.5
|
SECONDARY outcome
Timeframe: up to 5 yearsBreast 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 measures
| Measure |
Single Arm, Open Label
n=194 Participants
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.
|
|---|---|
|
Breast Cancer Survival.
|
96.7 Percentage of participants
Interval 92.2 to 98.6
|
Adverse Events
Single Arm, Open Label
Serious events: 0 serious events
Other events: 97 other events
Deaths: 21 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm, Open Label
n=206 participants at risk
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.
|
|---|---|
|
General disorders
Pain
|
18.9%
39/206 • Number of events 41 • Adverse events were collected through 2 years post-procedure, and serious adverse events (SAEs) were collected through the final follow-up (5 years post-procedure).
|
|
General disorders
Localized Edema
|
18.9%
39/206 • Number of events 40 • Adverse events were collected through 2 years post-procedure, and serious adverse events (SAEs) were collected through the final follow-up (5 years post-procedure).
|
|
Injury, poisoning and procedural complications
Bruising
|
29.6%
61/206 • Number of events 62 • Adverse events were collected through 2 years post-procedure, and serious adverse events (SAEs) were collected through the final follow-up (5 years post-procedure).
|
|
Injury, poisoning and procedural complications
Frost Injury
|
2.4%
5/206 • Number of events 5 • Adverse events were collected through 2 years post-procedure, and serious adverse events (SAEs) were collected through the final follow-up (5 years post-procedure).
|
|
Vascular disorders
Hematoma
|
4.4%
9/206 • Number of events 9 • Adverse events were collected through 2 years post-procedure, and serious adverse events (SAEs) were collected through the final follow-up (5 years post-procedure).
|
|
Skin and subcutaneous tissue disorders
Rash & Pruritus
|
1.9%
4/206 • Number of events 4 • Adverse events were collected through 2 years post-procedure, and serious adverse events (SAEs) were collected through the final follow-up (5 years post-procedure).
|
|
General disorders
Injection site reaction
|
4.9%
10/206 • Number of events 11 • Adverse events were collected through 2 years post-procedure, and serious adverse events (SAEs) were collected through the final follow-up (5 years post-procedure).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place