Breast Cancer Clinical Trial

Cryoablation vs Lumpectomy in T1 Breast Cancers

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.

View Eligibility Criteria

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.
Has electrical devices or implant (contraindicated for MRI).
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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

256

Study ID:

NCT05505643

Recruitment Status:

Recruiting

Sponsor:

Washington University School of Medicine

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There is 1 Location for this study

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Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Heather Garrett, M.D.
Contact
636-916-9662
[email protected]
Heather Garrett, M.D.
Principal Investigator
Robert McKinstry, M.D.
Sub-Investigator
Debbie Bennett, M.D.
Sub-Investigator
Julie Margenthaler, M.D.
Sub-Investigator
Katherine Clifton, M.D.
Sub-Investigator
Anurag Chahal, M.D.
Sub-Investigator
Jingqin Luo, Ph.D.
Sub-Investigator
Christina Doherty, M.D.
Sub-Investigator
Tabassum Ahmad, M.D.
Sub-Investigator
Imran Zoberi, M.D.
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

256

Study ID:

NCT05505643

Recruitment Status:

Recruiting

Sponsor:


Washington University School of Medicine

How clear is this clinincal trial information?

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