Recruiting

Cryoablation vs. Lumpectomy

Sponsor:

Washington University School of Medicine

Code:

NCT05505643

Conditions

Breast Cancer

Breast Neoplasm

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Endocare SlimLine Cryoprobe

Lumpectomy

Study Details

Brief summary:

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

Breast Cancer

Breast Neoplasm

Study ID

NCT05505643

Start date

Apr 3, 2024

Status verified date

Feb, 2026

Completion date

Apr 30, 2033

Anticipated

Primary completion date

Apr 30, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Lumpectomy

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

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.

experimental: Cryoablation - Safety Lead In

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

Interventions

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.

Lumpectomy

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

Primary outcome measure

  • 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) ]
  • Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast. [ Time Frame: At 5 years. ]

Central Contacts and Locations

Central contacts

Heather Garrett, M.D.

636-916-9662hvgarrett@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Heather Garrett, M.D.

636-916-9662hvgarrett@wustl.edu

Principal Investigator:

Heather Garrett, M.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • breast cancer
  • cryoablation
  • lumpectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-02-27.