Breast Cancer Clinical Trial
Cryoablation vs Lumpectomy in T1 Breast Cancers
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.
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).
Oncotype score < 26.
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.
Indication for neoadjuvant chemotherapy.
Presence of BRCA 1 and/or BRCA 2 mutation.
Prior history of breast cancer.
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.
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There is 1 Location for this study
Saint Louis Missouri, 63110, United States More Info
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