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Cryoablation vs Lumpectomy in T1 Breast Cancers

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About this study

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.

Condition
Breast Cancer, Breast Neoplasm
Tested
Endocare SlimLine Cryoprobe, Lumpectomy
Sponsor
Washington University School of Medicine

Who can join

Age
50 years and older
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 50 years
  • Eligible sex: Female
  • Study condition: Breast Cancer, Breast Neoplasm
  • 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 cm or less).
  • 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 separate tumor from the IDC).
  • 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.
  • Negative ipsilateral axillary assessment as determined either by (1) negative axillary ultrasound (2) negative sentinel lymph node biopsy or (3) negative percutaneous axillary node biopsy with no further clinical or imaging concern for nodal metastatic disease.
  • Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion 6

  • 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.
  • Tumoral involvement of skin or chest wall.

Where

1 site, 1 recruiting

Washington University School of Medicine

St Louis, Missouri, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.