Trial Title:
Cryoablation vs Lumpectomy in T1 Breast Cancers
NCT ID:
NCT05505643
Condition:
Breast Cancer
Breast Neoplasm
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
cryoablation
lumpectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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 236 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)
Intervention:
Intervention type:
Device
Intervention name:
Endocare SlimLine Cryoprobe
Description:
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.
Arm group label:
Cryoablation
Arm group label:
Cryoablation - Safety Lead In
Intervention type:
Procedure
Intervention name:
Lumpectomy
Description:
Patients randomized to cryoablation who experience disease recurrence may undergo
crossover to lumpectomy.
Arm group label:
Lumpectomy
Arm group label:
Rescue Arm: Lumpectomy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Garrett, M.D.
Phone:
636-916-9662
Email:
hvgarrett@wustl.edu
Investigator:
Last name:
Heather Garrett, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Robert McKinstry, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Debbie Bennett, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Julie Margenthaler, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Katherine Clifton, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Anurag Chahal, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Jingqin Luo, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Christina Doherty, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Tabassum Ahmad, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Imran Zoberi, M.D.
Email:
Sub-Investigator
Start date:
April 3, 2024
Completion date:
October 31, 2031
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
The Foundation for Barnes-Jewish Hospital
Agency class:
Other
Collaborator:
Agency:
Varian Medical Systems
Agency class:
Industry
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05505643
http://www.siteman.wustl.edu