Cryoablation vs Lumpectomy in T1 Breast Cancers

NCT05505643 | Recruiting DMC FDA Device

• 1 other identifier: 202302017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

breast cancer; cryoablation; lumpectomy

Outcome Measures

Primary Outcomes (2)

• Safety Lead-In: Number of treatment-related complications

  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.

  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.

  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.

  At 5 years.

Secondary Outcomes (3)

• Proportion of patients who are free of serious treatment-related complications

  Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)

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

  Through 5 years.

• Overall survival (OS)

  Through 5 years.

Study Arms (4)

Cryoablation

EXPERIMENTAL

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

Lumpectomy

ACTIVE COMPARATOR

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

Procedure: Lumpectomy

Rescue Arm: Lumpectomy

OTHER

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

Cryoablation - Safety Lead In

EXPERIMENTAL

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

Device: Endocare SlimLine Cryoprobe

Interventions

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.

Cryoablation; Cryoablation - Safety Lead In

Lumpectomy PROCEDURE

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

Lumpectomy; Rescue Arm: Lumpectomy

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator
• Varian Medical Systems: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Heather Garrett, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Garrett, M.D.

CONTACT

636-916-9662; hvgarrett@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 18, 2022
• Study Start: April 3, 2024
• Primary Completion (Estimated): April 30, 2033
• Study Completion (Estimated): April 30, 2033
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Proposals should be directed to hvgarrett@wustl.edu.

Locations

US (1)