Clinical trial NCT02200705: Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial
Official title: Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: cryoablation, cryotherapy, breast cancer
Lead sponsor: IceCure Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 206
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage 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

Primary outcomes:
measure: Local Inbreast Breast Tumor Recurrence (IBTR) Rate
timeFrame: up to 5 years
Secondary outcomes:
measure: Complete Ablation of Primary Tumor
timeFrame: up to 5 years from procedure date.
measure: Improvement or Maintenance of Subject's Quality of Life
timeFrame: at 6 months compare to the base line
measure: Breast Cosmetics Satisfaction
timeFrame: up to 5 years from procedure data.
measure: Regional Recurrence Rate
timeFrame: up to 5 years
measure: Distant Metastases Rate
timeFrame: up to 5 years
measure: Disease-free Survival (DFS)
timeFrame: up to 5 years
measure: Overall Survival
timeFrame: up to 5 years
measure: Breast Cancer Survival.
timeFrame: up to 5 years
measure: Adverse Events
timeFrame: up to 2 years for AEs and up to 5 years for SAEs
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: Santa Ana
country: United States
facility: BreastLink
state: California
city: Trumbull
country: United States
facility: Bridgeport Hospital, Yale Medical School
state: Connecticut
city: Dalton
country: United States
facility: Dalton Surgical Group
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Flint
country: United States
facility: Regional Medical Imaging
state: Michigan
city: Troy
country: United States
facility: Comprehensive Breast Care
state: Michigan
city: Freehold
country: United States
facility: CentraState Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Breast Specialty care/ Presbyterian Hospital
state: New Mexico
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: Columbia University/ NY Presbyterian hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Breast Surgeons Inc.
state: Ohio
city: Cleveland
country: United States
facility: University hospitals cleveland medical center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University hospital
state: Pennsylvania
city: Germantown
country: United States
facility: West Clinic
state: Tennessee
city: Plano
country: United States
facility: Complete Breast Care
state: Texas
Study officials:
References: