Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial

Breast Cancer Clinical Trial

Official title:

Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200705
• Other study ID #: ICMBC-02
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: May 26, 2024

Study information

• Verified date: May 2024
• Source: IceCure Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: May 26, 2024
• Est. primary completion date: March 17, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Ice-Sense3TM/ ProSenseTM

Locations

Country	Name	City	State
United States	Breast Specialty care/ Presbyterian Hospital	Albuquerque	New Mexico
United States	Cincinnati Breast Surgeons Inc.	Cincinnati	Ohio
United States	University hospitals cleveland medical center	Cleveland	Ohio
United States	Dalton Surgical Group	Dalton	Georgia
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Regional Medical Imaging	Flint	Michigan
United States	CentraState Medical Center	Freehold	New Jersey
United States	West Clinic	Germantown	Tennessee
United States	Ironwood Cancer & Research Centers	Glendale	Arizona
United States	Indiana University	Indianapolis	Indiana
United States	Columbia University/ NY Presbyterian hospital	New York	New York
United States	Montefiore Medical Center	New York	New York
United States	Mount Sinai Beth Israel	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Thomas Jefferson University hospital	Philadelphia	Pennsylvania
United States	Complete Breast Care	Plano	Texas
United States	BreastLink	Santa Ana	California
United States	Comprehensive Breast Care	Troy	Michigan
United States	Bridgeport Hospital, Yale Medical School	Trumbull	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
IceCure Medical Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local Inbreast Breast Tumor Recurrence (IBTR) rate	6 months post cryoabltion , then annually for 5 years	up to 5 years
Secondary	Complete ablation of primary tumor up to 60 months after cryoablation	Complete ablation of primary tumor	up to 5 years from procedure date.
Secondary	Improvement or maintenance of subject's quality of life	Quality of life will be assesed using NCCN DISTRESS THERMOMETER	at 6 months compare to the base line
Secondary	Breast cosmetics satisfaction	subjects and physician satisfaction from the cosmetic results	up to 5 years from procedure data.
Secondary	Regional recurrence rate	Regional Invasive breast tumor recurrence rate.	up to 5 years
Secondary	Distant metastases rate	Distant metastases rate including contralateral Breast cancer	up to 5 years
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	up to 5 years
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	up to 5 years
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.	up to 5 years
Secondary	Adverse events	Adverse events related to study device or procedure rate	up to 2 years for AEs and up to 5 years for SAEs