Cryoablation vs Lumpectomy in T1 Breast Cancers

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Aug 15, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for women with early-stage breast cancer called cryoablation, which works by freezing the tumor to kill it. Traditionally, the standard treatment for this type of cancer is a lumpectomy, where the tumor and some surrounding tissue are surgically removed. The study aims to determine whether cryoablation is as safe and effective as lumpectomy, looking specifically at how well it controls the cancer, the rates of complications, and the overall quality of life for patients.

To be eligible for this trial, women must be at least 50 years old and have a specific type of early-stage breast cancer that meets certain criteria, including that the tumor is small (2 cm or less) and not spread to lymph nodes. Participants will be asked to sign a consent form and will receive careful monitoring throughout the study. This research could potentially lead to less invasive treatment options for breast cancer, which might be beneficial for many women facing a cancer diagnosis.

Gender

FEMALE

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.
• • 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.