Actively Recruiting
COOL-IT: Cryoablation versus Lumpectomy for T1 Breast Cancers A Randomized Controlled Trial with Safety Lead-in
Led by Washington University School of Medicine · Updated on 2026-02-27
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
T
The Foundation for Barnes-Jewish Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of cryoablation compared to lumpectomy in women aged 50 and older with low risk, early stage breast cancer. This trial focuses on invasive ductal carcinoma that is estrogen receptor negative and HER-2 negative, with tumors 2 cm or less (T1N0M0). Cryoablation freezes and kills the tumor, offering a less invasive option than the standard lumpectomy surgery. The study will first review the safety of cryoablation and then compare outcomes such as disease control, complications, and quality of life between the two treatments. Participants will be assigned randomly to receive either cryoablation using the Endocare SlimLine Cryoprobe under local anesthesia with ultrasound guidance or lumpectomy performed under general anesthesia. Cryoablation involves a cycle of freezing, thawing, and refreezing the tumor tissue with possible adjustments based on tumor size. If follow-up imaging detects remaining or returning tumor after cryoablation, patients may receive a rescue lumpectomy and further treatment. After cryoablation, patients also receive additional standard treatments as needed. During the study, participants will undergo imaging evaluations including MRI and mammography at 6 months and yearly thereafter to monitor for cancer recurrence. Researchers will track complications related to treatment within 30 days and measure cancer recurrence in the treated breast over five years. Additional outcomes include disease-free and overall survival rates. The study spans long-term follow-up to assess safety, effectiveness, and quality of life in patients receiving either cryoablation or lumpectomy.
CONDITIONS
Brief Title
Cryoablation vs Lumpectomy in T1 Breast Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of invasive ductal carcinoma of the breast (ER negative, HER-2 negative) that is grade 1 or 2 with intraductal component less than 25%
- Tumor size must be T1N0M0 (2 cm or less)
- DCIS present in biopsy must be less than 25% of tumor and contiguous with IDC
- Oncotype score less than 26 for certain tumor subsets as specified
- At least 50 years old
- Negative ipsilateral axillary assessment by ultrasound, sentinel lymph node biopsy, or percutaneous axillary node biopsy
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Indication for neoadjuvant chemotherapy
- Prior history of breast cancer
- Breast augmentation
- Allergy to local anesthetics
- Pregnant or lactating; women of childbearing potential must have negative pregnancy test within 14 days prior to study entry
- Tumor involvement of skin or chest wall
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
Participants receive treatment either by cryoablation using the Endocare SlimLine Cryoprobe or by lumpectomy under general anesthesia according to their randomization.
1 treatment visit (in-person)
Duration - 30 days
Participants are monitored for treatment-related complications and recovery for 30 days after the cryoablation treatment or lumpectomy.
Approximately 2 to 3 visits
Duration - Up to 5 years
Participants undergo follow-up imaging evaluations, including MRI and mammography, to monitor for residual or recurrent tumor and to assess long-term outcomes.
1 MRI at 6 months (if tolerated) and yearly MRI/mammography visits
Duration - As needed after detection of recurrence
Participants initially treated with cryoablation who show evidence of residual or recurrent tumor on follow-up imaging may undergo a rescue lumpectomy followed by standard adjuvant treatment.
1 surgical visit plus follow-up visits as per standard care
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
H
Heather Garrett, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here