NCT05505643 · Washington University School of Medicine
Cryoablation vs Lumpectomy in T1 Breast Cancers
(COOL-IT)
What this study is about
This trial studies the effectiveness 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Safety Lead-In: Number of treatment-related complications
Time frame: Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)
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.
Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast.
Time frame: At 5 years.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- St Louis, Missouri
Collaborators
The Foundation for Barnes-Jewish Hospital, Varian Medical Systems
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations