Cryoablation vs Lumpectomy in T1 Breast Cancers

Last updated: July 21, 2025
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Endocare SlimLine Cryoprobe

Lumpectomy

Clinical Study ID

NCT05505643
202302017
  • Ages > 50
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of invasive ductal carcinoma of the breast (ER , Her-2 negative) that isgrade 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 shouldbe 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 inthis 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 consentdocument.

Exclusion

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 negativepregnancy 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

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Endocare SlimLine Cryoprobe
Phase:
Study Start date:
April 03, 2024
Estimated Completion Date:
April 30, 2033

Connect with a study center

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.