Cryoablation vs Lumpectomy in T1 Breast Cancers (COOL-IT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Neoplasm
• Intervention / Treatment: Device: Endocare SlimLine Cryoprobe; Procedure: Lumpectomy

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Garrett, M.D.; Phone Number: 636-916-9662; Email: hvgarrett@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Heather Garrett, M.D.; Phone Number: 636-916-9662; Email: hvgarrett@wustl.edu
      • Principal Investigator: Heather Garrett, M.D.
      • Sub-Investigator: Robert McKinstry, M.D.
      • Sub-Investigator: Debbie Bennett, M.D.
      • Sub-Investigator: Christina Doherty, M.D.
      • Sub-Investigator: Tabassum Ahmad, M.D.
      • Sub-Investigator: Jingqin Luo, Ph.D.
      • Sub-Investigator: Katherine Clifton, M.D.
      • Sub-Investigator: Julie Margenthaler, M.D.
      • Sub-Investigator: Imran Zoberi, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of invasive ductal carcinoma of the breast (ER , Her-2 negative) that is grade 1 or 2 with intraductal component <25%. Must be T1N0M0 (2 cm or less).
• If DCIS is present in the biopsy specimen it should be <25% of the tumor and should be contiguous with the IDC. (i.e. DCIS should not be a separate tumor from the IDC).
• 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.
• Negative ipsilateral axillary assessment as determined either by (1) negative axillary ultrasound (2) negative sentinel lymph node biopsy or (3) negative percutaneous axillary node biopsy with no further clinical or imaging concern for nodal metastatic disease.
• Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

• Indication for neoadjuvant chemotherapy.
• Prior history of breast cancer.
• Breast augmentation.
• Allergy to local anesthetics.
• Pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
• Tumoral involvement of skin or chest wall.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryoablation; Patients will be treated with cryoablation using the Endocare SlimLine Cyroprobe under real time ultrasound guidance and local anesthesia. The cryoablation consists of a 10 minute freeze phase followed by a 10 minute passive thaw, and ends with a second 10 minute freeze cycle. The freeze-thaw-freeze times may be adjusted at the physician's discretion depending on tumor size.	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.
Active Comparator: Lumpectomy; Lumpectomy will be performed under general anesthesia as per standard operative procedures at Washington University and Siteman Cancer Center.	Procedure: Lumpectomy; Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.
Experimental: Cryoablation - Safety Lead In; Patients will be treated with cryoablation (Day 1) using the Endocare SlimLine Cyroprobe followed by adjuvant treatment.	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.
Other: Rescue Arm: Lumpectomy; If there is evidence of residual or recurrent tumor on follow-up imaging evaluation (6 month MRI (if can tolerate) and yearly MRI/mammography), patients in the cryoablation safety lead-in and who were randomized to receive cryoablation only will be crossed over to receive a rescue lumpectomy followed by adjuvant treatment based on standard of care.	Procedure: Lumpectomy; Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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.
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.

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: The Foundation for Barnes-Jewish Hospital; Varian Medical Systems
• Investigators: Principal Investigator: Heather Garrett, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Estimated): April 30, 2033
• Study Completion (Estimated): April 30, 2033

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; cryoablation; lumpectomy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Surgical Procedures, Operative; Mastectomy; Mastectomy, Segmental
• Other Study ID Numbers: 202302017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the de-identified individual participant data and the study protocol will be made available to investigators who provide a methodologically sound proposal. Proposals should be directed to hvgarrett@wustl.edu. De- identified individual participant data will also be made available to Varian.
• IPD Sharing Access Criteria: Proposals should be directed to hvgarrett@wustl.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes