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

The Washington University

Status

Enrolling

Conditions

Breast Cancer

Breast Neoplasm

Treatments

Device: Endocare SlimLine Cryoprobe

Procedure: Lumpectomy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05505643

202302017

Details and patient eligibility

About

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.

Enrollment

256 estimated patients

Sex

Female

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of invasive ductal carcinoma of the breast of Luminal type A (ER/PR positive, Her-2 negative) that is grade 1 or 2 with intraductal component <25%. Must be T1N0M0 (2 cm or less).
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.
Mass must be visible on ultrasound and >5 mm from skin and chest wall muscles.
Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion criteria

Indication for neoadjuvant chemotherapy.
Presence of BRCA 1 and/or BRCA 2 mutation.
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.
DCIS present beyond the proposed ablation zone on MRI, mammography, or ultrasound.
Positive axillary lymph nodes as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

256 participants in 4 patient groups

Cryoablation

Experimental group

Description:

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.

Treatment:

Device: Endocare SlimLine Cryoprobe

Lumpectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Lumpectomy

Rescue Arm: Lumpectomy

Other group

Description:

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.

Treatment:

Procedure: Lumpectomy

Cryoablation - Safety Lead In

Experimental group

Description:

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

Treatment:

Device: Endocare SlimLine Cryoprobe