← Back to Search

Cryoablation

Cryoablation vs Lumpectomy for Early Stage Breast Cancer (COOL-IT Trial)

N/A

Recruiting

Led By Heather Garrett, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 5 years.

Awards & highlights

COOL-IT Trial Summary

This trial is studying whether cryoablation is a safe and effective treatment for low risk, early stage breast cancer.

Who is the study for?

This trial is for women over 50 with early-stage, low-risk breast cancer (T1N0M0, Luminal A type, ER/PR positive, Her-2 negative) that's visible on ultrasound and not too close to the skin or chest muscles. Participants must have a specific Oncotype score if applicable and can't be pregnant or breastfeeding. They should not have had breast cancer before, no BRCA mutations, no electrical implants incompatible with MRI, and no allergy to local anesthetics.Check my eligibility

What is being tested?

The study compares cryoablation—a technique of freezing tumors—with lumpectomy—the standard surgical removal of tumors—in treating T1 stage breast cancer. It aims to assess which method offers better disease control and quality of life while monitoring safety and complication rates.See study design

What are the potential side effects?

Potential side effects from cryoablation may include pain at the treatment site, bruising or bleeding under the skin, infection risk at the probe insertion point. Lumpectomy might cause temporary swelling or tenderness in the breast area as well as risks associated with surgery such as infection.

COOL-IT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My breast cancer has an Oncotype score below 26.

Select...

My tumor can be seen on an ultrasound and is not too close to my skin or chest muscles.

Select...

My breast cancer is early stage, hormone receptor positive, HER2 negative, and not aggressive.

Select...

I am 50 years old or older.

COOL-IT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast.

Safety Lead-In: Number of treatment-related complications

Secondary outcome measures

Overall survival (OS)

Proportion of patients who are free of serious treatment-related complications

Proportion of patients who demonstrate disease-free survival (DFS)

COOL-IT Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Rescue Arm: LumpectomyExperimental Treatment1 Intervention

If there is evidence of residual or recurrent tumor on follow-up imaging evaluation (6 month MRI 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.

Group II: Cryoablation - Safety Lead InExperimental Treatment1 Intervention

Patients will be treated with cryoablation (Day 1) using the Endocare SlimLine Cyroprobe followed by adjuvant treatment.

Group III: CryoablationExperimental Treatment1 Intervention

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.

Group IV: LumpectomyActive Control1 Intervention

Lumpectomy will be performed under general anesthesia as per standard operative procedures at Washington University and Siteman Cancer Center.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lumpectomy

2008

N/A

~670

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,551 Total Patients Enrolled

46 Trials studying Breast Cancer

4,912 Patients Enrolled for Breast Cancer

The Foundation for Barnes-Jewish HospitalOTHER

37 Previous Clinical Trials

6,525 Total Patients Enrolled

6 Trials studying Breast Cancer

406 Patients Enrolled for Breast Cancer

Varian Medical SystemsIndustry Sponsor

58 Previous Clinical Trials

3,483 Total Patients Enrolled

1 Trials studying Breast Cancer

66 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Clinical Trial 2023: Endocare SlimLine Cryoprobe Highlights & Side Effects. Trial Name: NCT05505643 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this endeavor currently underway?

"Clinicaltrials.gov indicates that this trial is no longer actively enrolling patients; its inception was on November 30th 2022 and the last update occurred in August 15th 2022. Notwithstanding, there are 2602 other medical studies currently recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cryoablation vs Lumpectomy in T1 Breast Cancers

2024. "Cryoablation vs Lumpectomy in T1 Breast Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05505643.

All > Breast Cancer Hawaii