Cryoablation vs Lumpectomy in T1 Breast Cancers

Breast Cancer Clinical Trial

— COOL-IT  

Official title:

COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505643
• Other study ID #: 202302017
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2024
• Est. completion date: October 31, 2031

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Heather Garrett, M.D.
• Phone: 636-916-9662
• Email: hvgarrett[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor by freezing it. The standard approach for patients with this kind of cancer is a lumpectomy. This study will review the safety of the cryoablation procedure initially, followed by comparing cryoablation to lumpectomy in order to see if the cryoablation results in better disease control, complication rates, and quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: October 31, 2031
• Est. primary completion date: October 31, 2031
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of invasive ductal carcinoma of the breast of Luminal type A (ER/PR positive, Her-2 negative) that is grade 1 or 2 with intraductal component <25%. Must be T1N0M0 (2 cm or less).

• Oncotyping will be performed on T1b+Allred<6/8 and T1c tumors. Oncotype score in this subset of patients must be <26 to be included in the trial.

• At least 50 years of age.

• Mass must be visible on ultrasound and >5 mm from skin and chest wall muscles.

• Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

• Indication for neoadjuvant chemotherapy.

• Presence of BRCA 1 and/or BRCA 2 mutation.

• Prior history of breast cancer.

• Breast augmentation.

• Allergy to local anesthetics.

• Has electrical devices or implant (contraindicated for MRI).

• Pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.

• DCIS present beyond the proposed ablation zone on MRI, mammography, or ultrasound.

• Positive axillary lymph nodes as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasm
• Breast Neoplasms

Intervention

Device:
• Endocare SlimLine Cryoprobe
The Endocare(TM) SlimLine (TM) Cryoprobe is a single use, disposable device designed for use with Endocare Cryocare Surgical Systems. Endocare cryoprobes are designed to deliver cold temperatures for cryoablation using high-pressure argon gas circulated through the cryoprobe, followed by active thawing using helium gas. The Cryocare CS Surgical System is intended for use in open, minimally invasive, or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures.

Procedure:
• Lumpectomy
Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	The Foundation for Barnes-Jewish Hospital, Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Lead-In: Number of treatment-related complications	Excessive adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. They are defined as toxicities occurring within 30 days after the cryoablation procedure and are at least possibly related to the cryoablation. These include death, life-threatening adverse events, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or complications related to cryoablation which interfere with adjuvant therapy such that the adjuvant therapy cannot be performed at all or delayed for a period longer than 6 months or which result in unplanned mastectomy.	Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)
Primary	Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast.	IBTR defined from date of procedure to date of ipsilateral breast cancer recurrence, with the occurrence of ipsilateral breast tumor recurrence as the event and patients will be censored at the last follow-up.	At 5 years.
Secondary	Proportion of patients who are free of serious treatment-related complications	Excessive adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. They are defined as toxicities occurring within 30 days after the cryoablation procedure and are at least possibly related to the cryoablation. These include death, life-threatening adverse events, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or complications related to cryoablation which interfere with adjuvant therapy such that the adjuvant therapy cannot be performed at all or delayed for a period longer than 6 months or which result in unplanned mastectomy.	Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)
Secondary	Proportion of patients who demonstrate disease-free survival (DFS)	DFS is defined as the time from procedure to time of ipsilateral recurrence, contralateral recurrence, regional recurrence or distant metastasis, or date of last follow-up if none of the recurrence events occur.	Through 5 years.
Secondary	Overall survival (OS)	OS is defined from date of procedure to date of death or date of last follow up if none of the recurrence events occur.	Through 5 years.

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine