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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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. - 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. - 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. - Positive axillary lymph nodes as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The initial 20 participants will be enrolled to a safety lead-in arm receiving cryoablation. The next 100 participants will be randomized in a 1:1 manner to either cryoablation or lumpectomy. Patients initially treated with cryoablation who have evidence of residual or recurrent tumor on follow-up imaging will be crossed over to receive a rescue lumpectomy.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cryoablation 		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.
  • 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.
Active Comparator
Lumpectomy 		Lumpectomy will be performed under general anesthesia as per standard operative procedures at Washington University and Siteman Cancer Center.
  • Procedure: Lumpectomy
    Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.
Other
Rescue Arm: Lumpectomy 		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.
  • Procedure: Lumpectomy
    Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.
Experimental
Cryoablation - Safety Lead In 		Patients will be treated with cryoablation (Day 1) using the Endocare SlimLine Cyroprobe followed by adjuvant treatment.
  • 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.

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Heather Garrett, M.D.
636-916-9662
hvgarrett@wustl.edu

More Details

NCT ID
NCT05505643
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Heather Garrett, M.D.
636-916-9662
hvgarrett@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.