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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

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