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.

Trial Details

NCT ID
NCT05505643
Phase
NA
Sponsor
Washington University School of Medicine
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Endocare SlimLine Cryoprobe
  • Lumpectomy
Locations (sample)
  • St Louis, Missouri, United States|38.62727,-90.19789

Key Eligibility Criteria

  • Diagnosis of invasive ductal carcinoma of the breast (ER , Her-2 negative) that is grade 1 or 2 with intraductal component \<25%. Must be T1N0M0 (2…
  • If DCIS is present in the biopsy specimen it should be \<25% of the tumor and should be contiguous with the IDC. (i.e. DCIS should not be a separat…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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