Cryoablation vs Lumpectomy in T1 Breast Cancers

Description

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.

Conditions

Breast Cancer, Breast Neoplasm

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Study Overview

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Study Details

Study overview

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.

COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in

Cryoablation vs Lumpectomy in T1 Breast Cancers

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Indication for neoadjuvant chemotherapy.
  • * Presence of BRCA 1 and/or BRCA 2 mutation.
  • * 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.

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Washington University School of Medicine,

Heather Garrett, M.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

2031-10-31