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NCT Number: NCT05505643

Cryoablation vs Lumpectomy in T1 Breast Cancers

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasm Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endocare SlimLine Cryoprobe

Device

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.

Lumpectomy

Procedure

Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Proportion of patients who are free of serious 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.

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

    Time frame: Through 5 years.

    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.

  3. Overall survival (OS)

    Time frame: Through 5 years.

    OS is defined from date of procedure to date of death or date of last follow up if none of the recurrence events occur.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • The Foundation for Barnes-Jewish Hospital
  • Varian Medical Systems

Registry information

Official study title

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

Acronym: COOL-IT

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Aug 18, 2022
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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